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

Official Title: “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)”

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Vardenafil HCl (Levitra, BAY38-9456)
  • vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
• Placebo Comparator: Placebo
  • vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Primary Measures

• Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeks
  • Time Frame: baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)
    Safety Issue?: No
• Change From Baseline in Average Number of Daily Micturitions at 6 Weeks
  • Time Frame: baseline and up to 6 weeks of treatment LOCF
    Safety Issue?: No

Secondary Measures

• Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks
  • Time Frame: baseline and up to 6 weeks of treatment LOCF
    Safety Issue?: No
• Change From Baseline in Volume at First Detectable Leakage at 6 Weeks
  • Time Frame: baseline and up to 6 weeks of treatment LOCF
    Safety Issue?: No
• Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks
  • Time Frame: baseline and up to 6 weeks of treatment LOCF
    Safety Issue?: No
• Change From Baseline in Volume at First Desire to Void at 6 Weeks
  • Time Frame: baseline and up to 6 weeks of treatment LOCF
    Safety Issue?: No
• Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks
  • Time Frame: baseline and up to 6 weeks of treatment LOCF
    Safety Issue?: No
• Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks
  • Time Frame: baseline and up to 6 weeks of treatment LOCF
    Safety Issue?: No
• Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older
  • Time Frame: baseline and up to 6 weeks of treatment LOCF
    Safety Issue?: No
• Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks
  • Time Frame: baseline and up to 6 weeks of treatment LOCF
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00478881

Study ID Number: 12392

ClinicalTrials.gov Identifier: NCT00478881

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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