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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 Weeks

Change 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 Weeks

Change 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

Click here and search for drug information provided by the FDA.

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Click here to find results for studies related to Bayer Healthcare products.

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Starting date: August 2007
Last updated: November 24, 2014

Page last updated: August 23, 2015

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