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NCT00510406 Clinical Trial

A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH

Lower Urinary Tract Symptoms Clinical Trial

— SATURN  

Official title:
A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00510406
Other study ID # 905-CL-052
Secondary ID EudraCT number:
Status Completed
Phase Phase 2
First received July 31, 2007
Last updated August 19, 2014
Start date January 2007
Est. completion date September 2007

Study information
Verified date August 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and WomenBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: Ethics CommitteeNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Ministry of HealthPortugal: National Pharmacy and Medicines InstituteSlovakia: State Institute for Drug ControlSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNorway: Norwegian Medicines AgencyRussia: Ministry of Health of the Russian Federation
Study type Interventional

Clinical Trial Summary

The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.

Description:

Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride + solifenacin succinate

The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy.

Other comparisons will be:

Placebo and combination treatment. Solifenacin monotherapy and combination treatment

Recruitment information / eligibility
Status Completed
Enrollment 919
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Male
Age group 45 Years and older
Eligibility Inclusion Criteria:

- male patients with LUTS associated with BPH diagnosed > 3 months

- IPSS score > 13

- voiding and storage symptoms

- maximum flow rate of > 4 mL/s and < 15 mL/s

Exclusion Criteria:

- post void residual volume > 200 mL

- symptomatic urinary tract infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tamsulosin hydrochloride
Alphablocker
• solifenacin succinate
antimuscarinic
• Placebo
Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Austria,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Hungary,  Netherlands,  Norway,  Poland,  Portugal,  Russian Federation,  Slovakia,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH 12 weeks No
Secondary Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride 12 weeks No
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