Trial Condition(s):
Overactive Bladder, Detrusor Overactivity
A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function
Bayer Identifier:
12392
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Universitätsklinikum Essen Essen, Germany, 45147 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Stefan Carl & Dr. Achim Forth Emmendingen, Germany, 79312 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Reha-Zentrum Passauer Wolf Bad Griesbach-Therme, Germany, 94086 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Nordoberpfalz AG - Klinikum Weiden Weiden, Germany, 92637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. K.-U. Laval Düsseldorf, Germany, 40235 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. Roth / Wins Wuppertal, Germany, 42103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Leipzig AöR Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asklepios Klinikum Uckermark Schwedt, Germany, 16303 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städtisches Klinikum Neunkirchen gemeinnützige GmbH Neunkirchen, Germany, 66538 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Tenon - Paris PARIS CEDEX 20, France, 75970 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Paris, France, 75571 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia Obrazen Warszawa, Poland, 02-005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NZOZ Centrum Medyczne Wola Warszawa, Poland, 01-432 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. E. Heßdörfer Berlin, Germany, 13347 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken Maria Hilf GmbH Mönchengladbach, Germany, 41063 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Hedwig Krankenhaus Berlin, Germany, 10115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Ernst-Moritz-Arndt-Universität Greifswald, Germany, 17475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Leczenia Chorób Cywilizacyjnych Warszawa, Poland, 02-777 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Slaskie Centrum Urologii "Urovita" Chorzow, Poland, 41-500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NZOZ Urolog - Poradnia Urologiczna Bydgoszcz, Poland, 85-168 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uroprojekt s.c. - Gabinet urologiczny Siedlce, Poland, 08-110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario "La Paz" Madrid, Spain, 28046 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Virgen de las Nieves Granada, Spain, 18014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urology Associates Kitchener, Canada, N2N 2B9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Brantford Urology Research Brantford, Canada, N3R 4N3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Academisch Ziekenhuis Maastricht MAASTRICHT, Netherlands, 6229 HX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Catharina EINDHOVEN, Netherlands, 5623 EJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr. Steinhoff Clinical Research Victoria, Canada, V8V 3N1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vrije Universiteit Medisch Centrum AMSTERDAM, Netherlands, 1081 HV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Medical Center Utrecht UTRECHT, Netherlands, 3584 CX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Erasmus Medisch Centrum ROTTERDAM, Netherlands, 3015 CE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Academisch Medisch Centrum Universiteit van Amsterdam AMSTERDAM, Netherlands, 1105 AZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Androgeos - private center of urology and andrology Praha 6, Czech Republic, 160 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni Thomayerova Nemocnice Praha 4, Czech Republic, 140 59 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni Nemocnice Olomouc Olomouc, Czech Republic, 775 20 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shaare Zedek Medical Center Jerusalem, Israel, 91031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto, Portugal, 4050-013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site S. Martinho do Bispo, Portugal, 3046-853 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Santo António Oporto Porto, Portugal, 4099-001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Budai Egeszsegkozpont Kft Budapest , Hungary, 1126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Municipal Clinical Hospital N50 Moscow, Russia, 125206 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Andros Urological Clinic St. Petersburg, Russia, 198013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Research Institute of Urology Moscow, Russia, 105425 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rambam Medical Center Haifa, Israel, 31096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rabin Medical Center Petach Tikva, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Amadora, Portugal, 2720-276 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lisboa, Portugal, 1069-166 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Semmelweis Budapest, Hungary, 1082 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 WeeksTimeframe: baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)
- Change From Baseline in Average Number of Daily Micturitions at 6 WeeksTimeframe: baseline and up to 6 weeks of treatment LOCF
Secondary Outcome
- Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 WeeksTimeframe: baseline and up to 6 weeks of treatment LOCF
- Change From Baseline in Volume at First Detectable Leakage at 6 WeeksTimeframe: baseline and up to 6 weeks of treatment LOCF
- Change From Baseline in Maximum Cystometric Bladder Capacity at 6 WeeksTimeframe: baseline and up to 6 weeks of treatment LOCF
- Change From Baseline in Volume at First Desire to Void at 6 WeeksTimeframe: baseline and up to 6 weeks of treatment LOCF
- Change From Baseline in Average Number of Urgencies Per Day at 6 WeeksTimeframe: baseline and up to 6 weeks of treatment LOCF
- Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 WeeksTimeframe: baseline and up to 6 weeks of treatment LOCF
- Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and OlderTimeframe: baseline and up to 6 weeks of treatment LOCF
- Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 WeeksTimeframe: baseline and up to 6 weeks of treatment LOCF
Additional Information
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