Clinical trial NCT00527605: Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)
Official title: A Randomized, Double-blind, Placebo-controlled, Six-month Parallel-group Study to Assess Efficacy and Safety of Dutasteride 0.5mg Once Daily in Chinese Patients With Benign Prostatic Hyperplasia (BPH), Followed by a 12-month Open-label Treatment Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Prostatic Hyperplasia
Keywords: placebo control
Chinese
Dutasteride
Randomized
Benign Prostatic Hyperplasia
Double blind
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-09-11
Enrollment: 253
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 randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH) , followed by a 12-month open-label treatment phase


Eligibility criteria: Inclusion:

* Clinical diagnosis of BPH
* AUA-SI \>=12 \[American Urological Association Symptom Index\]
* Qmax \> 5ml/sec and \<=15ml/sec and minimum voided volume of \>=125ml
* Prostate volume \>=30cm(3)

Exclusion:

* Post void residual volume \>250ml
* History or evidence of prostate cancer
* Total serum PSA \<1.5ng/ml or \>10.0ng/ml (Prostate specific antigen)
* Previous prostatic surgery or other invasive procedures to treat BPH.
* History of AUR (Acute Urinary Retention) within 3 months
* History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days
* Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate
* History of hepatic impairment or abnormal liver function tests
* Use of any 5a-reductase inhibitors ,any drugs with antiandrogenic properties or other drugs noted for gynaecomastia effects, or could affect prostate volume, within past 6 months and throughout the study
* Use of alpha-receptor blockers within 2 weeks and throughout the study.
* Use of phytotherapy for BPH within 2 weeks and/or predicted to need phytotherapy during the study.
* Concurrent use of anabolic steroids
* Use of any alpha-adrenergic agonists or cholinergics within 48 hours prior to uroflowmetry assessment.
* Hypersensitivity to any 5a-reductase inhibitor or other chemically-related drugs.
* Actively trying to procreate or unwilling to wear a condom during intercourse with a woman of childbearing potential for duration of participation in this study and 16 weeks following treatment.
* History or current evidence of drug or alcohol abuse within the previous 12 months.
* 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, of cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
* History of renal insufficiency, or serum creatinine \>1.5xULN (Upper Limit of Normal )
* Participation in any investigational or marketed drug trial within 30 days and during the course of the study.

Primary outcomes:
measure: Percent Change From Baseline in the Prostate Volume at Month 6
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Percent Change From Baseline in the Prostate Volume at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in the Prostate Volume at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in the Prostate Volume at Month 3
timeFrame: Baseline and Month 3
measure: Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6
timeFrame: Baseline and Month 6
measure: Percent Change From Baseline in the Serum DHT at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in the Serum DHT at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in the Serum DHT at Month 3
timeFrame: Baseline and Month 3
measure: Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6
timeFrame: Baseline and Month 6
measure: Percent Change From Baseline in the AUA-SI Score at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in the AUA-SI Score at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in the AUA-SI Score at Month 3
timeFrame: Baseline and Month 3
measure: Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6
timeFrame: Baseline and Month 6
measure: Percent Change From Baseline in Qmax at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in Qmax at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Qmax at Month 3
timeFrame: Baseline and Month 3
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: GSK Investigational Site
state: Guangdong
city: Wuhan
country: China
facility: GSK Investigational Site
state: Hubei
city: Nanjing
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Hangzhou
country: China
facility: GSK Investigational Site
state: Zhejiang
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Tianjin
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Na Y, Ye Z, Zhang S. Efficacy and Safety of Dutasteride in Chinese Adults with Symptomatic Benign Prostatic Hyperplasia : A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study with an Open-Label Extension. Clin Drug Investig. 2012 Jan;32(1):29-39. doi: 10.2165/11593750-000000000-00000.
citation: Na Y, Ye Z, Zhang S; Chinese Dutasteride Phase III Trial (ARIA108898) Study Group. Efficacy and safety of dutasteride in Chinese adults with symptomatic benign prostatic hyperplasia: a randomized, double-blind, parallel-group, placebo-controlled study with an open-label extension. Clin Drug Investig. 2012 Jan 1;32(1):29-39. doi: 10.2165/11593750-000000000-00000.