Clinical trial NCT00090103: Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
Official title: A Randomized, Double-blind, Parallel Group Study to Investigate the Efficacy and Safety of Treatment With Dutasteride (0.5mg) and Tamsulosin (0.4mg), Administered Once Daily for 4 Years, Alone and Combination, on the Improvement of Symptoms and Clinical Outcome in Men With Moderate to Severe Symptomatic Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Hyperplasia
Keywords: Combination Therapy
dutasteride
BPH
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2004-08-26
Enrollment: 4844
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.

Detailed description: A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5 mg) and Tamsulosin (0.4 mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia.

Eligibility criteria: Inclusion criteria:

* A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
* males, aged ≥50 years
* clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE)
* International Prostate Symptom Score (IPSS) ≥12 points at Screening
* prostate volume ≥30 cc by transrectal ultrasonography; (TRUS)
* total serum Prostate Specific Antigen (PSA) ≥1.5ng/mL at Screening
* maximum flow rate (Qmax) \>5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids)
* willing and able to give written informed consent and comply with study procedures
* fluent and literate in local language with the ability to read, comprehend and record information on the IPSS, BII and Patient Perception of Study Medication
* able to swallow and retain oral medication
* willing and able to participate in the study for the full 4 years.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

* total serum PSA \>10.0ng/mL at Screening
* history or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study.

Note: If total serum PSA is \>4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further DRE, review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice.

* previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH.
* history of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to the Screening Visit. Routine catheterisation is acceptable with no time restriction.
* history of AUR within 3 months prior to Screening Visit.
* post-void residual volume \>250mL (suprapubic ultrasound) at Screening.
* any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections).
* history of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy.
* use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®, Avodart®), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents), or other drugs which affect prostate volume, within past 6 months of the Screening Visit and throughout the study (other than as study medication).
* concurrent use of anabolic steroids
* use of phytotherapy for BPH within 2 weeks of Screening Visit and/or predicted to need phytotherapy during the study.
* use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 2 weeks of Screening Visit and/or predicted to need any alpha blockers other than tamsulosin during the study.

Note: the purpose of this criteria is to be able to standardise baseline symptom severity for all enrolled patients prior to randomisation and not to specifically exclude current alpha-adrenoreceptor blocker users from participation in the study.

* use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine) or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol chloride) within 48 hours prior to all uroflowmetry assessments.
* hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs.
* concurrent use of drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin.
* history of hepatic impairment or abnormal liver function tests at Screening defined as alanine aminotransferase (ALT), aspartate aminotranferase (AST), and/or alkaline phosphatase \>2 times the upper limit of normal, or total bilirubin \>1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome).
* history of renal insufficiency, or serum creatinine \>1.5 times the upper limit of normal or serum creatinine ≥1.5 mg/dL at Screening.
* prior history of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible.
* history of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient.
* any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
* history of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury.
* history of unsuccessful treatment with tamsulosin or 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy.
* history of unsuccessful treatment with finasteride or dutasteride
* history or current evidence of drug or alcohol abuse within the previous 12 months.
* participation in any investigational or marketed drug trial within 30 days (or 5 half-lives whichever is the longer) preceding the Screening Visit and/or during the course of this study.

Primary outcomes:
measure: Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.
timeFrame: Years 1, 2, 3, and 4
measure: Number of Participants With AUR or BPH-related Surgery
timeFrame: Baseline (Day 1) through Year 4
Secondary outcomes:
measure: Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4
timeFrame: Years 1, 2, 3, and 4
measure: The Number of Participants With Each of the Five Components of BPH Clinical Progression
timeFrame: Baseline (Day 1) to Year 4
measure: Number of Events of Symptom Deterioration at the Indicated Time Periods
timeFrame: Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)
measure: Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria
timeFrame: Baseline (Day 1) through Year 4
measure: Number of Participants With an Event of Post-baseline BPH-related Hematospermia
timeFrame: Baseline (Day 1) through Year 4
measure: Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
timeFrame: Every 3 months from Month 3 to Month 48
measure: Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned"?.
timeFrame: Every 3 months from Month 3 to Month 48
measure: Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
timeFrame: Every 3 months from Month 3 to Month 48
measure: Number of "Yes" Responses to the Question: "Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"
timeFrame: Every 3 months from Month 3 to Month 48
measure: Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
timeFrame: Every 3 months from Month 3 to Month 48
measure: Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
timeFrame: Every 3 months from Month 3 to Month 48
measure: Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48
timeFrame: Baseline and Months 12, 24, 36, 48
measure: Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
timeFrame: Baseline and Months 12, 24, 36, and 48
measure: Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
timeFrame: Baseline and Months 12, 24, 36, and 48
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
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state: Alabama
city: Columbiana
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state: Alabama
city: Hoover
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state: Alabama
city: Anchorage
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state: Alaska
city: Phoenix, Arizona
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facility: GSK Investigational Site
state: Arizona
city: Phoenix
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city: Beverly Hills
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city: Glendora
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state: California
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state: California
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city: La Jolla
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city: Laguna Woods
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state: California
city: Los Angeles
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state: California
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city: Modesto
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city: Sacramento
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state: California
city: San Diego
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city: San Diego
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city: Lewiston
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state: New York
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state: North Carolina
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state: North Carolina
city: Charlotte
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state: North Carolina
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state: North Carolina
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state: North Carolina
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state: North Dakota
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state: Ohio
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state: Ohio
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state: Ohio
city: Columbus
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state: Ohio
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state: Oregon
city: Fleetwood
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state: Pennsylvania
city: Providence
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state: Rhode Island
city: Nashville
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state: Tennessee
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state: Texas
city: Dallas
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facility: GSK Investigational Site
state: Texas
city: Dallas
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facility: GSK Investigational Site
state: Texas
city: Dallas
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state: Texas
city: Fort Worth
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state: Texas
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state: Texas
city: Houston
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state: Texas
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state: Texas
city: San Antonio
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state: Texas
city: Temple
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state: Texas
city: Texarkana
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state: Texas
city: Salt Lake City
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state: Utah
city: Alexandria
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state: Virginia
city: Bellevue
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state: Washington
city: Mountlake Terrace
country: United States
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state: Washington
city: Seattle
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state: Washington
city: Spokane
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state: Washington
city: Tacoma
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state: Washington
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
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facility: GSK Investigational Site
city: Buenos Aires
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facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad de Buenos Aires
country: Argentina
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city: Antwerpen
country: Belgium
facility: GSK Investigational Site
city: Brussels
country: Belgium
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city: Brussel
country: Belgium
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city: Edegem
country: Belgium
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state: Minas Gerais
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country: Brazil
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state: Rio Grande Do Sul
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state: Rio Grande Do Sul
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city: Sofia
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city: Sofia
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city: Varna
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city: Surrey
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Saint John
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Saint John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Kentville
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Barrie
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Brantford
country: Canada
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state: Ontario
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country: Canada
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state: Ontario
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country: Canada
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state: Ontario
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country: Canada
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state: Ontario
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country: Canada
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state: Ontario
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state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
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facility: GSK Investigational Site
state: Ontario
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state: Ontario
city: Montreal
country: Canada
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state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
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country: Canada
facility: GSK Investigational Site
state: Quebec
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state: Quebec
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state: Quebec
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facility: GSK Investigational Site
state: Quebec
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city: Ostrava - Poruba
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city: Praha 3
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country: Czech Republic
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country: Czech Republic
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city: Roudnice nad Labem
country: Czech Republic
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country: Denmark
facility: GSK Investigational Site
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country: Denmark
facility: GSK Investigational Site
city: Fredericia
country: Denmark
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country: Denmark
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city: Tallinn
country: Estonia
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city: Tallinn
country: Estonia
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city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
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country: Finland
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city: Kuopio
country: Finland
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country: Finland
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country: Finland
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city: Bully Les Mines
country: France
facility: GSK Investigational Site
state: Nord-Pas-de-Calais
city: Agny
country: France
facility: GSK Investigational Site
city: Angers
country: France
facility: GSK Investigational Site
city: Annecy
country: France
facility: GSK Investigational Site
city: Arras
country: France
facility: GSK Investigational Site
city: Athis Mons Cedex
country: France
facility: GSK Investigational Site
city: Besançon
country: France
facility: GSK Investigational Site
city: Bouchemaine
country: France
facility: GSK Investigational Site
city: Broglie
country: France
facility: GSK Investigational Site
city: Castelneau Le Nez
country: France
facility: GSK Investigational Site
city: Chambery
country: France
facility: GSK Investigational Site
city: Chambéry
country: France
facility: GSK Investigational Site
city: Chilly Mazarin
country: France
facility: GSK Investigational Site
city: Cournonterral
country: France
facility: GSK Investigational Site
city: Créteil cedex
country: France
facility: GSK Investigational Site
city: Domarin
country: France
facility: GSK Investigational Site
city: Epinay sur Orge
country: France
facility: GSK Investigational Site
city: Evreux Cedex
country: France
facility: GSK Investigational Site
city: Evreux
country: France
facility: GSK Investigational Site
city: Gif-sur-Yvette
country: France
facility: GSK Investigational Site
city: Grenoble
country: France
facility: GSK Investigational Site
city: La Seyne sur Mer
country: France
facility: GSK Investigational Site
city: Lamarque
country: France
facility: GSK Investigational Site
city: Laval
country: France
facility: GSK Investigational Site
city: Le Brusc
country: France
facility: GSK Investigational Site
city: Le Kremlin-Bicêtre
country: France
facility: GSK Investigational Site
city: Les Mureaux
country: France
facility: GSK Investigational Site
city: Lesparre Médoc
country: France
facility: GSK Investigational Site
city: Linas
country: France
facility: GSK Investigational Site
city: Longpont sur Orge
country: France
facility: GSK Investigational Site
city: Lyon
country: France
facility: GSK Investigational Site
city: Melun
country: France
facility: GSK Investigational Site
city: Meudon
country: France
facility: GSK Investigational Site
city: Meylan
country: France
facility: GSK Investigational Site
city: Mont de Marsan
country: France
facility: GSK Investigational Site
city: Montauban
country: France
facility: GSK Investigational Site
city: Montpelier
country: France
facility: GSK Investigational Site
city: Montpellier
country: France
facility: GSK Investigational Site
city: Montpellier
country: France
facility: GSK Investigational Site
city: Orléans Cedex 2
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Pontonx Sur Adour
country: France
facility: GSK Investigational Site
city: Roanne
country: France
facility: GSK Investigational Site
city: Saint Chamond
country: France
facility: GSK Investigational Site
city: Saint Denis
country: France
facility: GSK Investigational Site
city: Saint Galmier
country: France
facility: GSK Investigational Site
city: Saint Germain Lespinasse
country: France
facility: GSK Investigational Site
city: Saint Sebastien de Morsent
country: France
facility: GSK Investigational Site
city: Saint-Egrève
country: France
facility: GSK Investigational Site
city: Saint-Georges d'Orques
country: France
facility: GSK Investigational Site
city: Sainte Suzanne
country: France
facility: GSK Investigational Site
city: Sanary
country: France
facility: GSK Investigational Site
city: Sarlat la Canéda
country: France
facility: GSK Investigational Site
city: Seysses
country: France
facility: GSK Investigational Site
city: Six-Fours les Plages
country: France
facility: GSK Investigational Site
city: Suresnes Cedex
country: France
facility: GSK Investigational Site
city: Toulon
country: France
facility: GSK Investigational Site
city: Tours
country: France
facility: GSK Investigational Site
city: Vaucresson
country: France
facility: GSK Investigational Site
city: Verneuil-sur-Seine
country: France
facility: GSK Investigational Site
city: Villejuif Cedex
country: France
facility: GSK Investigational Site
city: Villeneuve-Les-Maguelone
country: France
facility: GSK Investigational Site
city: Vourey
country: France
facility: GSK Investigational Site
city: Aalen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Konstanz
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mosbach
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Rottweil
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stockach
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Aichach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Amberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Augsburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Graefeling
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Neu-Ulm
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Schongau
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wertingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Hagenow
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Lauchhammer
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Oranienburg
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Senftenberg
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Alzenau
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Fulda
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Giessen
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Koenigstein
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Marburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Schwalbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Grimmen
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Parchim
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Delmenhorst
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Holzminden
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Oldenburg
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Osnabrueck
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Duelmen
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Stadtlohn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Koblenz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Hettstedt
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Merseburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Hohenstein-Ernsttal
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Husum
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Apolda
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Patra
country: Greece
facility: GSK Investigational Site
city: Polygyros
country: Greece
facility: GSK Investigational Site
city: Thassaloniki
country: Greece
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Sopron
country: Hungary
facility: GSK Investigational Site
city: Székesfehérvár
country: Hungary
facility: GSK Investigational Site
city: Veszprém
country: Hungary
facility: GSK Investigational Site
city: Reykjavik
country: Iceland
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Holon
country: Israel
facility: GSK Investigational Site
city: Kfar Saba
country: Israel
facility: GSK Investigational Site
city: Ramat Gan
country: Israel
facility: GSK Investigational Site
city: Zrifin
country: Israel
facility: GSK Investigational Site
city: Catanzaro
country: Italy
facility: GSK Investigational Site
state: Calabria
city: Avellino
country: Italy
facility: GSK Investigational Site
state: Campania
city: Castellamare di Stabia (NA)
country: Italy
facility: GSK Investigational Site
state: Campania
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: San Felice a Cancello Caserta
country: Italy
facility: GSK Investigational Site
state: Campania
city: Torre del Greco (NA)
country: Italy
facility: GSK Investigational Site
state: Campania
city: Modena
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Udine
country: Italy
facility: GSK Investigational Site
state: Friuli-Venezia-Giulia
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Lecco
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Ivrea (TO)
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Novara
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Torino
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Cagliari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Acireale (CT)
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Bagno a Ripoli (FI)
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Firenze
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Siena
country: Italy
facility: GSK Investigational Site
state: Toscana
city: Portogruaro (VE)
country: Italy
facility: GSK Investigational Site
state: Veneto
city: Pusan
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Klaipeda
country: Lithuania
facility: GSK Investigational Site
city: Klaipeda
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Zapopan, Jalisco
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Zapopan
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Mexico DF
country: Mexico
facility: GSK Investigational Site
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Alkmaar
country: Netherlands
facility: GSK Investigational Site
city: Amstelveen
country: Netherlands
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Arnhem
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Doetinchem
country: Netherlands
facility: GSK Investigational Site
city: Enschede
country: Netherlands
facility: GSK Investigational Site
city: Etten-leur
country: Netherlands
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Heerlen
country: Netherlands
facility: GSK Investigational Site
city: Hilversum
country: Netherlands
facility: GSK Investigational Site
city: Hoofddorp
country: Netherlands
facility: GSK Investigational Site
city: Maastricht
country: Netherlands
facility: GSK Investigational Site
city: Tilburg
country: Netherlands
facility: GSK Investigational Site
city: Tilburg
country: Netherlands
facility: GSK Investigational Site
city: Veldhoven
country: Netherlands
facility: GSK Investigational Site
city: Winterswijk
country: Netherlands
facility: GSK Investigational Site
city: Zwijndrecht
country: Netherlands
facility: GSK Investigational Site
city: Aalesund
country: Norway
facility: GSK Investigational Site
city: Bergen
country: Norway
facility: GSK Investigational Site
city: Bodø
country: Norway
facility: GSK Investigational Site
city: Haugesund
country: Norway
facility: GSK Investigational Site
city: Moelv
country: Norway
facility: GSK Investigational Site
city: Nøtterøy
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Porsgrunn
country: Norway
facility: GSK Investigational Site
city: Tønsberg
country: Norway
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Abrantes
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Porto
country: Portugal
facility: GSK Investigational Site
city: Porto
country: Portugal
facility: GSK Investigational Site
city: S. Martinho do Bispo
country: Portugal
facility: GSK Investigational Site
city: Ponce
country: Puerto Rico
facility: GSK Investigational Site
city: Santurce
country: Puerto Rico
facility: GSK Investigational Site
city: Arad
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Cluj-Napoca
country: Romania
facility: GSK Investigational Site
city: Iasi
country: Romania
facility: GSK Investigational Site
city: Timisoara
country: Romania
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Rostov-na-Donu
country: Russian Federation
facility: GSK Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Smolensk
country: Russian Federation
facility: GSK Investigational Site
city: Banska Bystrica
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Kosice
country: Slovakia
facility: GSK Investigational Site
city: Martin
country: Slovakia
facility: GSK Investigational Site
city: Skalica
country: Slovakia
facility: GSK Investigational Site
city: Zilina
country: Slovakia
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Claremont
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Sunninghill
country: South Africa
facility: GSK Investigational Site
city: Alava
country: Spain
facility: GSK Investigational Site
city: Alcázar de San Juan (Ciudad Real)
country: Spain
facility: GSK Investigational Site
city: Badajoz
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Burgos
country: Spain
facility: GSK Investigational Site
city: Ciudad Real
country: Spain
facility: GSK Investigational Site
city: Elche (Alicante)
country: Spain
facility: GSK Investigational Site
city: Gijon
country: Spain
facility: GSK Investigational Site
city: Guadalajara
country: Spain
facility: GSK Investigational Site
city: Jerez de la Frontera
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: Langreo (Oviedo)
country: Spain
facility: GSK Investigational Site
city: Las Palmas De Gran Canaria
country: Spain
facility: GSK Investigational Site
city: Las Palmas
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Manacor (Palma de Mallorca)
country: Spain
facility: GSK Investigational Site
city: Marbella
country: Spain
facility: GSK Investigational Site
city: Mendaro, Guipuzcoa
country: Spain
facility: GSK Investigational Site
city: Merida
country: Spain
facility: GSK Investigational Site
city: Murcia
country: Spain
facility: GSK Investigational Site
city: Palma de Mallorca
country: Spain
facility: GSK Investigational Site
city: Pamplona
country: Spain
facility: GSK Investigational Site
city: Pontevedra
country: Spain
facility: GSK Investigational Site
city: Sabadell (Barcelona)
country: Spain
facility: GSK Investigational Site
city: San Sebastian
country: Spain
facility: GSK Investigational Site
city: San Sebastián
country: Spain
facility: GSK Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Tortosa
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Vigo (Pontevedra)
country: Spain
facility: GSK Investigational Site
city: Vigo/Pontevedra
country: Spain
facility: GSK Investigational Site
city: Vitoria
country: Spain
facility: GSK Investigational Site
city: Vizcaya
country: Spain
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Tainan
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Chiangmai
country: Thailand
facility: GSK Investigational Site
city: Sousse
country: Tunisia
facility: GSK Investigational Site
city: Tunis
country: Tunisia
facility: GSK Investigational Site
city: Tunis
country: Tunisia
facility: GSK Investigational Site
city: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Izmir
country: Turkey
facility: GSK Investigational Site
city: Sıhhiye/Ankara
country: Turkey
facility: GSK Investigational Site
city: Swansea
country: United Kingdom
facility: GSK Investigational Site
state: Glamorgan
city: Buckshaw Village, Chorley
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Northwood
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
state: Midlothian
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
state: Oxfordshire
city: Chichester
country: United Kingdom
facility: GSK Investigational Site
state: Sussex West
city: Clydebank, Glasgow
country: United Kingdom
facility: GSK Investigational Site
city: Dundee
country: United Kingdom
facility: GSK Investigational Site
city: Edgbaston, Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Waterloo, Liverpool
country: United Kingdom
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Antonanzas F, Brenes F, Molero JM, Fernandez-Pro A, Huerta A, Palencia R, Cozar JM. [Cost-effectiveness of the combination therapy of dutasteride and tamsulosin in the treatment of benign prostatic hyperlasia in Spain]. Actas Urol Esp. 2011 Feb;35(2):65-71. doi: 10.1016/j.acuro.2010.11.008. Epub 2011 Jan 26. Spanish.
citation: Barkin J, Roehrborn CG, Siami P, Haillot O, Morrill B, Black L, Montorsi F; CombAT Study Group. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial. BJU Int. 2009 Apr;103(7):919-26. doi: 10.1111/j.1464-410X.2009.08196.x. Epub 2009 Feb 23.
citation: Bjerklund Johansen TE, Baker TM, Black LK. Cost-effectiveness of combination therapy for treatment of benign prostatic hyperplasia: a model based on the findings of the Combination of Avodart and Tamsulosin trial. BJU Int. 2012 Mar;109(5):731-8. doi: 10.1111/j.1464-410X.2011.10511.x. Epub 2011 Sep 20.
citation: Black L, Grove A, Morrill B. The psychometric validation of a US English satisfaction measure for patients with benign prostatic hyperplasia and lower urinary tract symptoms. Health Qual Life Outcomes. 2009 Jun 19;7:55. doi: 10.1186/1477-7525-7-55.
citation: Chung BH, Roehrborn CG, Siami P, Major-Walker K, Morrill BB, Wilson TH, Montorsi F. Efficacy and safety of dutasteride, tamsulosin and their combination in a subpopulation of the CombAT study: 2-year results in Asian men with moderate-to-severe BPH. Prostate Cancer Prostatic Dis. 2009;12(2):152-9. doi: 10.1038/pcan.2008.49. Epub 2008 Sep 23.
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