Clinical trial NCT01021332: Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
Official title: An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Keywords: Vesomni
Solifenacin succinate
EC905
Tamsulosin hydrochloride OCAS
Treatment
Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-11-26
Enrollment: 1067
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.

Detailed description: This is an open-label extension study following the double blind 905-CL-055 study

Eligibility criteria: Inclusion Criteria:

* Completion of 12 weeks double-blind treatment in Study 905-CL-055

Exclusion Criteria:

* Any significant PVR volume (\>150 mL)

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)
measure: Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])
timeFrame: Baseline and up to 52 weeks of FDC treatment
Secondary outcomes:
measure: Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in IPSS Voiding Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in IPSS Storage Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Individual IPSS Scores
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Symptom Bother Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Number of OAB-q Responders Based on Health-related Quality of Life: Total Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in EQ-5D Mobility Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in EQ-5D Self-care Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
measure: Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
timeFrame: Baseline and up to 52 weeks of FDC treatment
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Vienna
country: Austria
city: Minsk
country: Belarus
city: Minsk
country: Belarus
city: Minsk
country: Belarus
city: Antwerp
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liege 1
country: Belgium
city: Hradec Kralove
country: Czechia
city: Ostrava
country: Czechia
city: Plzen
country: Czechia
city: Roudnice nad Labem
country: Czechia
city: Uherske Hradiste
country: Czechia
city: Usti nad Labem
country: Czechia
city: Zd'ar nad Sazavou
country: Czechia
city: Colmar Cedex
country: France
city: Montlucon
country: France
city: Orleans cedex 2
country: France
city: Paris Cedex 10
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Bautzen
country: Germany
city: Frankfurt
country: Germany
city: Ganderkesee
country: Germany
city: Hagenow
country: Germany
city: Halle Saale
country: Germany
city: Hamburg
country: Germany
city: Henningsdorf
country: Germany
city: Hettstedt
country: Germany
city: Koblenz
country: Germany
city: Leipzig
country: Germany
city: Leipzig
country: Germany
city: Lutherstadt Eisleben
country: Germany
city: Neustadt in Sachsen
country: Germany
city: Radebeul
country: Germany
city: Sachsen
country: Germany
city: Trier
country: Germany
city: Uetersen
country: Germany
city: Avellino
country: Italy
city: Catanzaro
country: Italy
city: Palermo
country: Italy
city: Treviglio
country: Italy
city: Amsterdam
country: Netherlands
city: Apeldoorn
country: Netherlands
city: Doetinchem
country: Netherlands
city: Maastricht
country: Netherlands
city: Sneek
country: Netherlands
city: Tilburg
country: Netherlands
city: Winterswijk
country: Netherlands
city: Bielsko-Biala
country: Poland
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Pulawy
country: Poland
city: Warsaw
country: Poland
city: Wiecbork
country: Poland
city: Nitra
country: Slovakia
city: Piestany
country: Slovakia
city: Presov
country: Slovakia
city: Skalica
country: Slovakia
city: Trencin
country: Slovakia
city: Cardiff
country: United Kingdom
city: Chorley
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Northwood
country: United Kingdom
city: Oxford
country: United Kingdom
city: Reading
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Taunton
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Global Development
name: Use Central Contact
role: STUDY_CHAIR
References: