check_circleStudy Completed
Overactive Bladder, Detrusor Overactivity
Bayer Identifier:
12392
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function
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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
397Trial Dates
August 2007 - November 2008Phase
Phase 2Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Universitätsklinikum Essen | Essen, 45147, Germany |
Completed | Praxis Dr. Stefan Carl & Dr. Achim Forth | Emmendingen, 79312, Germany |
Completed | Reha-Zentrum Passauer Wolf | Bad Griesbach-Therme, 94086, Germany |
Completed | Kliniken Nordoberpfalz AG - Klinikum Weiden | Weiden, 92637, Germany |
Completed | Praxis Hr. Dr. K.-U. Laval | Düsseldorf, 40235, Germany |
Completed | Praxis Drs. Roth / Wins | Wuppertal, 42103, Germany |
Completed | Universitätsklinikum Leipzig AöR | Leipzig, 04103, Germany |
Completed | Asklepios Klinikum Uckermark | Schwedt, 16303, Germany |
Completed | Städtisches Klinikum Neunkirchen gemeinnützige GmbH | Neunkirchen, 66538, Germany |
Completed | Hôpital Tenon - Paris | PARIS CEDEX 20, 75970, France |
Completed | Paris, 75571, France | |
Completed | Szpital Kliniczny Dzieciatka Jezus -Centrum Leczenia Obrazen | Warszawa, 02-005, Poland |
Completed | NZOZ Centrum Medyczne Wola | Warszawa, 01-432, Poland |
Completed | Praxis Fr. Dr. E. Heßdörfer | Berlin, 13347, Germany |
Completed | Kliniken Maria Hilf GmbH | Mönchengladbach, 41063, Germany |
Completed | St. Hedwig Krankenhaus | Berlin, 10115, Germany |
Completed | Klinikum der Ernst-Moritz-Arndt-Universität | Greifswald, 17475, Germany |
Completed | Centrum Leczenia Chorób Cywilizacyjnych | Warszawa, 02-777, Poland |
Completed | Slaskie Centrum Urologii "Urovita" | Chorzow, 41-500, Poland |
Completed | NZOZ Urolog - Poradnia Urologiczna | Bydgoszcz, 85-168, Poland |
Completed | Uroprojekt s.c. - Gabinet urologiczny | Siedlce, 08-110, Poland |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Completed | Hospital Universitario "La Paz" | Madrid, 28046, Spain |
Completed | Hospital Universitario Virgen de las Nieves | Granada, 18014, Spain |
Completed | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela, 15706, Spain |
Completed | Urology Associates | Kitchener, N2N 2B9, Canada |
Completed | Brantford Urology Research | Brantford, N3R 4N3, Canada |
Completed | Academisch Ziekenhuis Maastricht | MAASTRICHT, 6229 HX, Netherlands |
Completed | Catharina | EINDHOVEN, 5623 EJ, Netherlands |
Completed | Hospital Clínico Universitario de Valencia | Valencia, 46010, Spain |
Completed | Sir Mortimer B. Davis Jewish General Hospital | Montreal, H3T 1E2, Canada |
Completed | Dr. Steinhoff Clinical Research | Victoria, V8V 3N1, Canada |
Completed | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Completed | Vrije Universiteit Medisch Centrum | AMSTERDAM, 1081 HV, Netherlands |
Completed | University Medical Center Utrecht | UTRECHT, 3584 CX, Netherlands |
Completed | Erasmus Medisch Centrum | ROTTERDAM, 3015 CE, Netherlands |
Completed | Academisch Medisch Centrum Universiteit van Amsterdam | AMSTERDAM, 1105 AZ, Netherlands |
Completed | Androgeos - private center of urology and andrology | Praha 6, 160 00, Czech Republic |
Completed | Fakultni Thomayerova Nemocnice | Praha 4, 140 59, Czech Republic |
Completed | Fakultni Nemocnice Olomouc | Olomouc, 775 20, Czech Republic |
Completed | Shaare Zedek Medical Center | Jerusalem, 91031, Israel |
Completed | Porto, 4050-013, Portugal | |
Completed | S. Martinho do Bispo, 3046-853, Portugal | |
Completed | Hospital Santo António Oporto | Porto, 4099-001, Portugal |
Completed | Budai Egeszsegkozpont Kft | Budapest, 1126, Hungary |
Completed | Municipal Clinical Hospital N50 | Moscow, 125206, Russia |
Completed | Andros Urological Clinic | St. Petersburg, 198013, Russia |
Completed | Research Institute of Urology | Moscow, 105425, Russia |
Completed | Universitätsspital Basel | Basel, 4031, Switzerland |
Completed | Rambam Medical Center | Haifa, 31096, Israel |
Completed | Rabin Medical Center | Petach Tikva, Israel |
Completed | Amadora, 2720-276, Portugal | |
Completed | Lisboa, 1069-166, Portugal | |
Completed | University of Semmelweis | Budapest, 1082, Hungary |
Completed | Research Institute of Urology | Moscow, 105425, Russia |
Primary Outcome
- Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 Weeksdate_rangeTime Frame:baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)enhanced_encryptionNoSafety Issue:
- Change From Baseline in Average Number of Daily Micturitions at 6 Weeksdate_rangeTime Frame:baseline and up to 6 weeks of treatment LOCFenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeksdate_rangeTime Frame:baseline and up to 6 weeks of treatment LOCFenhanced_encryptionNoSafety Issue:
- Change From Baseline in Volume at First Detectable Leakage at 6 Weeksdate_rangeTime Frame:baseline and up to 6 weeks of treatment LOCFenhanced_encryptionNoSafety Issue:
- Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeksdate_rangeTime Frame:baseline and up to 6 weeks of treatment LOCFenhanced_encryptionNoSafety Issue:
- Change From Baseline in Volume at First Desire to Void at 6 Weeksdate_rangeTime Frame:baseline and up to 6 weeks of treatment LOCFenhanced_encryptionNoSafety Issue:
- Change From Baseline in Average Number of Urgencies Per Day at 6 Weeksdate_rangeTime Frame:baseline and up to 6 weeks of treatment LOCFenhanced_encryptionNoSafety Issue:
- Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeksdate_rangeTime Frame:baseline and up to 6 weeks of treatment LOCFenhanced_encryptionNoSafety Issue:
- Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Olderdate_rangeTime Frame:baseline and up to 6 weeks of treatment LOCFenhanced_encryptionNoSafety Issue:
- Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeksdate_rangeTime Frame:baseline and up to 6 weeks of treatment LOCFenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2Additional Information
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