A Study To Assess If 10 mg Vardenafil (BAY 38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00478881

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.

Condition	Intervention	Phase
Overactive Bladder Detrusor Overactivity	Drug: Vardenafil HCl (Levitra, BAY38-9456) Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
Change From Baseline in Average Number of Daily Micturitions at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
Change From Baseline in Volume at First Detectable Leakage at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
Change From Baseline in Volume at First Desire to Void at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	397
Study Start Date:	August 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vardenafil HCl (Levitra, BAY38-9456): Experimental vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks	Drug: Vardenafil HCl (Levitra, BAY38-9456) vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
Placebo: Placebo Comparator vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks	Drug: Placebo vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 egenerative 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478881

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Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	12392, EudraCT: 2006-005145-11
Study First Received:	May 24, 2007
Results First Received:	November 16, 2009
Last Updated:	January 31, 2010
ClinicalTrials.gov Identifier:	NCT00478881 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Hungary: National Institute of Pharmacy; Israel: Israeli Health Ministry Pharmaceutical Administration; Italy: The Italian Medicines Agency; Netherlands: Medicines Evaluation Board (MEB); Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: National Pharmacy and Medicines Institute; Russia: Ministry of Health and Social Development of the Russian Federation

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Phosphodiesterase Inhibitors
Vardenafil

Molecular Mechanisms of Pharmacological Action
Urologic Diseases
Urinary Bladder Diseases
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010