A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder; Detrusor Overactivity
Intervention: Vardenafil HCl (Levitra, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
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)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Bladder Volume at First Detrusor Contraction at 6 WeeksChange From Baseline in Average Number of Daily Micturitions at 6 Weeks
Secondary outcome: Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 WeeksChange From Baseline in Volume at First Detectable Leakage at 6 Weeks Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks Change From Baseline in Volume at First Desire to Void at 6 Weeks Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks Change From Baseline in Average Number of Daily Involuntary Discharges of Urine at 6 Weeks Change From Baseline in Peak Urinary Flow at 6 Weeks in Men Aged 50 Years and Older Change From Baseline in the Total Score of the Overactive Bladder Questionnaire (OAB-q) at 6 Weeks
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Bruxelles - Brussel 1200, Belgium
Olomouc 775 20, Czech Republic
Praha 4 140 59, Czech Republic
Praha 6 160 00, Czech Republic
Paris Cedex 20 75970, France
Paris 75571, France
Berlin 10115, Germany
Berlin 13347, Germany
Budapest 1082, Hungary
Budapest 1126, Hungary
Haifa 31096, Israel
Jerusalem 91031, Israel
Petach Tikva, Israel
Amsterdam 1081 HV, Netherlands
Amsterdam 1105 AZ, Netherlands
Maastricht 6229 HX, Netherlands
Rotterdam 3015 CE, Netherlands
Utrecht 3584 CX, Netherlands
Bydgoszcz 85-168, Poland
Chorzow 41-500, Poland
Siedlce 08-110, Poland
Warszawa 01-432, Poland
Warszawa 02-005, Poland
Warszawa 02-777, Poland
Amadora 2720-276, Portugal
Lisboa 1069-166, Portugal
Porto 4099-001, Portugal
Porto 4050-013, Portugal
S. Martinho do Bispo 3046-853, Portugal
Moscow 105425, Russian Federation
Moscow 125206, Russian Federation
St. Petersburg 198013, Russian Federation
Barcelona 08035, Spain
Barcelona 08036, Spain
Granada 18014, Spain
Madrid 28046, Spain
Valencia 46010, Spain
Santiago de Compostela, A Coruña 15706, Spain
Emmendingen, Baden-Württemberg 79312, Germany
Basel, Basel-Stadt 4031, Switzerland
Bad Griesbach-Therme, Bayern 94086, Germany
Weiden, Bayern 92637, Germany
Schwedt, Brandenburg 16303, Germany
Victoria, British Columbia V8V 3N1, Canada
Greifswald, Mecklenburg-Vorpommern 17475, Germany
Eindhoven, Noord-Brabant 5623 EJ, Netherlands
Düsseldorf, Nordrhein-Westfalen 40235, Germany
Essen, Nordrhein-Westfalen 45147, Germany
Mönchengladbach, Nordrhein-Westfalen 41063, Germany
Wuppertal, Nordrhein-Westfalen 42103, Germany
Brantford, Ontario N3R 4N3, Canada
Kitchener, Ontario N2N 2B9, Canada
Montreal, Quebec H3T 1E2, Canada
Neunkirchen, Saarland 66538, Germany
Leipzig, Sachsen 04103, Germany
Additional Information
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Starting date: August 2007
Last updated: November 24, 2014
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