- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00478881
A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function
November 24, 2014 updated by: Bayer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
397
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bruxelles - Brussel, Belgium, 1200
-
-
-
-
British Columbia
-
Victoria, British Columbia, Canada, V8V 3N1
-
-
Ontario
-
Brantford, Ontario, Canada, N3R 4N3
-
Kitchener, Ontario, Canada, N2N 2B9
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
-
-
-
-
-
Olomouc, Czech Republic, 775 20
-
Praha 4, Czech Republic, 140 59
-
Praha 6, Czech Republic, 160 00
-
-
-
-
-
Paris, France, 75571
-
Paris Cedex 20, France, 75970
-
-
-
-
-
Berlin, Germany, 13347
-
Berlin, Germany, 10115
-
-
Baden-Württemberg
-
Emmendingen, Baden-Württemberg, Germany, 79312
-
-
Bayern
-
Bad Griesbach-Therme, Bayern, Germany, 94086
-
Weiden, Bayern, Germany, 92637
-
-
Brandenburg
-
Schwedt, Brandenburg, Germany, 16303
-
-
Mecklenburg-Vorpommern
-
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
-
-
Nordrhein-Westfalen
-
Düsseldorf, Nordrhein-Westfalen, Germany, 40235
-
Essen, Nordrhein-Westfalen, Germany, 45147
-
Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
-
Wuppertal, Nordrhein-Westfalen, Germany, 42103
-
-
Saarland
-
Neunkirchen, Saarland, Germany, 66538
-
-
Sachsen
-
Leipzig, Sachsen, Germany, 04103
-
-
-
-
-
Budapest, Hungary, 1082
-
Budapest, Hungary, 1126
-
-
-
-
-
Haifa, Israel, 31096
-
Jerusalem, Israel, 91031
-
Petach Tikva, Israel
-
-
-
-
-
Amsterdam, Netherlands, 1105 AZ
-
Amsterdam, Netherlands, 1081 HV
-
Maastricht, Netherlands, 6229 HX
-
Rotterdam, Netherlands, 3015 CE
-
Utrecht, Netherlands, 3584 CX
-
-
Noord-Brabant
-
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
-
-
-
-
-
Bydgoszcz, Poland, 85-168
-
Chorzow, Poland, 41-500
-
Siedlce, Poland, 08-110
-
Warszawa, Poland, 01-432
-
Warszawa, Poland, 02-777
-
Warszawa, Poland, 02-005
-
-
-
-
-
Amadora, Portugal, 2720-276
-
Lisboa, Portugal, 1069-166
-
Porto, Portugal, 4099-001
-
Porto, Portugal, 4050-013
-
S. Martinho do Bispo, Portugal, 3046-853
-
-
-
-
-
Moscow, Russian Federation, 125206
-
Moscow, Russian Federation, 105425
-
St. Petersburg, Russian Federation, 198013
-
-
-
-
-
Barcelona, Spain, 08036
-
Barcelona, Spain, 08035
-
Granada, Spain, 18014
-
Madrid, Spain, 28046
-
Valencia, Spain, 46010
-
-
A Coruña
-
Santiago de Compostela, A Coruña, Spain, 15706
-
-
-
-
Basel-Stadt
-
Basel, Basel-Stadt, Switzerland, 4031
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vardenafil HCl (Levitra, BAY38-9456)
vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
|
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
|
vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Bladder volume was measure by means of urodynamic assessments (cystometry) for up to 6 weeks.
Missing data were imputed with last observation carried forward (LOCF).
|
baseline and up to 6 weeks of treatment Last Observation Carried Forward (LOCF)
|
Change From Baseline in Average Number of Daily Micturitions at 6 Weeks
Time Frame: baseline and up to 6 weeks of treatment LOCF
|
Change from baseline in the number of daily micturitions (bladder voidings), as reported in the participant diaries for up to 6 weeks.
Missing data were imputed with last observation carried forward (LOCF).
|
baseline and up to 6 weeks of treatment LOCF
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks
Time Frame: baseline and up to 6 weeks of treatment LOCF
|
Detrusor pressure was measured by means of urodynamic assessment (cystometry) for up to 6 weeks.
Missing data were imputed by last observation carried forward (LOCF).
|
baseline and up to 6 weeks of treatment LOCF
|
Change From Baseline in Volume at First Detectable Leakage at 6 Weeks
Time Frame: baseline and up to 6 weeks of treatment LOCF
|
First detectable leakage was determined by means of cystometry as an obligatory urodynamic measure.
Missing data was imputed by last observation carried forward (LOCF).
|
baseline and up to 6 weeks of treatment LOCF
|
Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks
Time Frame: baseline and up to 6 weeks of treatment LOCF
|
Maximum cystometric bladder capacity was defined as the volume at which either significant leakage or discomfort/pain occurred.
Missing data were imputed by last observation carried forward (LOCF).
|
baseline and up to 6 weeks of treatment LOCF
|
Change From Baseline in Volume at First Desire to Void at 6 Weeks
Time Frame: baseline and up to 6 weeks of treatment LOCF
|
Volume at first desire to void was recorded during urodynamic assessments.
Missing data were imputed by last observation carried forward (LOCF).
|
baseline and up to 6 weeks of treatment LOCF
|
Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks
Time Frame: baseline and up to 6 weeks of treatment LOCF
|
The average number of urgencies was derived from the number of urgencies reported by the participants in a 7 day micturition diary.
Missing data were imputed by last observation carried forward.
|
baseline and up to 6 weeks of treatment LOCF
|
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
|
The average number of daily involuntary discharges of urine was derived from the number of discharges reported by the participants in a 7 day micturition diary.
Missing data were imputed by last observation carried forward.
|
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 Older
Time Frame: baseline and up to 6 weeks of treatment LOCF
|
Peak urinary flow (Qmax) was measured using urodynamic assessments (voiding / flow cystometry) for up to 6 weeks.
Missing data were imputed by last observation carried forward (LOCF).
|
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 Weeks
Time Frame: baseline and up to 6 weeks of treatment LOCF
|
The OAB-q is a validated, self-administered questionnaire that quantifies bladder symptoms and quality of life.
It comprises 33 items (6-point scale for each item).
The total score ranges from 33 (minimum symptoms) to 198 (maximum symptoms).
On each item, participants provide their rating over the past 4 weeks.
Missing data were imputed by LOCF.
|
baseline and up to 6 weeks of treatment LOCF
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
May 24, 2007
First Submitted That Met QC Criteria
May 24, 2007
First Posted (Estimate)
May 25, 2007
Study Record Updates
Last Update Posted (Estimate)
December 11, 2014
Last Update Submitted That Met QC Criteria
November 24, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Vardenafil Dihydrochloride
Other Study ID Numbers
- 12392
- 2006-005145-11 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overactive Bladder
-
Ankara Yildirim Beyazıt UniversityCompletedOveractive Bladder | Overactive Detrusor | Overactive Bladder SyndromeTurkey
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedOveractive Bladder (OAB)United States, Canada, Germany, Korea, Republic of, Spain, Turkey, Taiwan, Italy, Slovakia, Denmark, South Africa, United Kingdom, Mexico, Sweden, Norway
-
Medstar Health Research InstituteColumbia University; University of Michigan; University of New Mexico; Methodist...Terminated
-
Astellas Pharma Global Development, Inc.CompletedOveractive Bladder (OAB)United States, Canada
-
Merck Sharp & Dohme LLCTerminatedOveractive Bladder | Overactive Urinary Bladder
-
Loyola UniversityAstellas Pharma IncCompletedOveractive Bladder SyndromeUnited States
-
Beijing Pins Medical Co., LtdUnknown
-
Maastricht University Medical CenterUnknownLower Urinary Tract Symptoms | Overactive Bladder SyndromeNetherlands
-
Pamukkale UniversityCompletedElectrical Stimulation | Idiopathic Overactive Bladder | Bladder TrainingTurkey
Clinical Trials on Vardenafil HCl (Levitra, BAY38-9456)
-
BayerCompleted
-
BayerGlaxoSmithKlineCompleted
-
BayerCompletedErectile DysfunctionBelgium, Finland, Germany, France, Denmark, United Kingdom, Spain
-
BayerCompletedErectile Dysfunction
-
BayerCompletedDepression | Erectile DysfunctionItaly, Spain, France, United States, Canada
-
BayerCompletedErectile DysfunctionHong Kong, Malaysia, Singapore, Thailand, Philippines, Indonesia
-
BayerGlaxoSmithKlineCompletedErectile DysfunctionUnited States, Canada
-
BayerGlaxoSmithKlineCompleted
-
BayerGlaxoSmithKlineCompleted