NCT01512004

Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

Phase III Study of Propiverine Hydrochloride Extended-Release Capsule in the Treatment of Overactive Bladder (OAB) in Chinese Population With Urgent Micturition, Frequent Micturition and/or Urge Urinary Incontinence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.

Detailed description

This is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison with Tolterodine Tartrate Extended-Release Tablet as active parallel control to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of Overactive Bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Propiverine Hydrochloride	drug of oral capsule
DRUG	Tolterodine Extended-release Tablet	4mg/tablet; oral; once per day

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-01-01
• Completion: 2011-08-01
• First posted: 2012-01-19
• Last updated: 2012-01-25

Locations

1 site across 1 country: China