NCT00478881

A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function

Randomized, Double-blind, Placebo-controlled, Parallel Group Study of Vardenafil 10 mg Twice Daily to Assess the Effect on Urodynamics in Patients With Overactive Bladder (Detrusor Overactivity)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 397 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency. The study drug is to be taken in the form of tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug works better than no drug. The timing of visits for the study is as follows: the 1st visit (screening visit) at beginning of run-in-assessment with qualifying tests for patients: electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit (randomization visit). During visit this should be performed: urodynamic measurements (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final visit)-following test should be done: urodynamic measurements (filling cystometry and pressure flow investigations), ECG, safety laboratory and residual urine (by ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.

Conditions

• Overactive Bladder
• Detrusor Overactivity

Interventions

Type	Name	Description
DRUG	Vardenafil HCl (Levitra, BAY38-9456)	vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
DRUG	Placebo	vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2007-05-25
• Last updated: 2014-12-11
• Results posted: 2009-12-24

Locations

55 sites across 13 countries: Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Netherlands, Poland, Portugal, Russia, Spain, Switzerland