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

NCT ID: NCT00478881

Last Updated: 2014-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 397 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2008-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vardenafil HCl (Levitra, BAY38-9456)

vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks

Group Type: EXPERIMENTAL

Vardenafil HCl (Levitra, BAY38-9456)

Intervention Type: DRUG

vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks

Placebo

vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Interventions

Vardenafil HCl (Levitra, BAY38-9456)

vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks

Intervention Type: DRUG

Placebo

vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female patients aged > 18 years (females either postmenopausal or using adequate birth control)
• Urodynamic criteria:

• Entire bladder capacity (= maximum cystometric bladder capacity) < 300 mL OR
• In accordance with International Continence Society (ICS)-guidelines: Detrusor overactivity as defined as spontaneous involuntary detrusor contraction during filling phase OR
• Detrusor contraction during filling phase leading to involuntarily initiated micturition before a normal bladder capacity is reached
• Patient micturition diary criteria: at least 8 micturitions per day AND at least 1 urgency episode per day
• Signed and dated written Patient Informed Consent Form

Exclusion Criteria

• Treatment with drugs known to affect urinary bladder function
• Known other reasons for micturition problems than detrusor overactivity
• Recent intervention in urogenital tract
• Abnormal liver or renal lab values
• Treatment with nitrates or nitric oxide donors, alpha-blockers, potent inhibitors of CYP-450 3A4, acenocoumarol, heparin, drugs known to prolong QT-interval
• NAION, hereditary regenerative retinal disorders, severe cardiovascular conditions, recent history of myocardial infarction/stroke/life-threatening arrhythmia
• congenital QT-prolongation, left ventricular outflow obstruction, severe hypo- or hypertension, symptomatic postural hypotension
• History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C
• Significant active peptic ulceration
• Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
• In men: Clinically significant chronic haematological disease which may lead to priapism
• History of malignancy of any organ system within the past 5 years
• Bleeding disorder

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Bruxelles - Brussel, , Belgium

Victoria, British Columbia, Canada

Brantford, Ontario, Canada

Kitchener, Ontario, Canada

Montreal, Quebec, Canada

Olomouc, , Czechia

Prague, , Czechia

Prague, , Czechia

Paris, , France

Paris, , France

Emmendingen, Baden-Wurttemberg, Germany

Bad Griesbach-Therme, Bavaria, Germany

Weiden, Bavaria, Germany

Schwedt, Brandenburg, Germany

Greifswald, Mecklenburg-Vorpommern, Germany

Düsseldorf, North Rhine-Westphalia, Germany

Essen, North Rhine-Westphalia, Germany

Mönchengladbach, North Rhine-Westphalia, Germany

Wuppertal, North Rhine-Westphalia, Germany

Neunkirchen, Saarland, Germany

Leipzig, Saxony, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Budapest, , Hungary

Budapest, , Hungary

Haifa, Israel, Israel

Jerusalem, Israel, Israel

Petah Tikva, Israel, Israel

Eindhoven, North Brabant, Netherlands

Amsterdam, , Netherlands

Amsterdam, , Netherlands

Maastricht, , Netherlands

Rotterdam, , Netherlands

Utrecht, , Netherlands

Bydgoszcz, , Poland

Chorzów, , Poland

Siedlce, , Poland

Warsaw, , Poland

Warsaw, , Poland

Warsaw, , Poland

Amadora, , Portugal

Lisbon, , Portugal

Porto, , Portugal

Porto, , Portugal

S. Martinho Do Bispo, , Portugal

Moscow, , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Santiago de Compostela, A Coruña, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Granada, Granada, Spain

Madrid, Madrid, Spain

Valencia, Valencia, Spain

Basel, Canton of Basel-City, Switzerland

Countries

Australia; Italy; South Africa; United Kingdom; Belgium; Canada; Czechia; France; Germany; Hungary; Israel; Netherlands; Poland; Portugal; Russia; Spain; Switzerland

Related Links

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

2006-005145-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12392

Identifier Type: -

Identifier Source: org_study_id