A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function

This study has been completed.

Study NCT00478881 Information provided by Bayer

First Received on May 24, 2007. Last Updated on April 28, 2011 History of Changes

Results First Received: November 16, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Overactive Bladder Detrusor Overactivity
Interventions:	Drug: Vardenafil HCl (Levitra, BAY38-9456) Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment started on 31 August 2007 and the last study visit occurred on 13 November 2008. The study was conducted at 56 centers in 13 countries: 45 centers in Europe, 4 centers in Canada, 4 centers in Russia, and 3 centers in Israel.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Number of participants screened: 635. Number of participants enrolled and randomized (started Overall study): 397. Number of participants who had taken at least one dose (Safety population): 396.

Reporting Groups

	Description
Vardenafil HCl (Levitra, BAY38-9456)	vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
Placebo	vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Participant Flow: Overall Study

	Vardenafil HCl (Levitra, BAY38-9456)	Placebo
STARTED	199	198
Received Medication	198	198
COMPLETED	160	176
NOT COMPLETED	39	22
Adverse Event	31	12
Lack of Efficacy	0	3
Lost to Follow-up	0	1
Protocol Violation	2	2
Withdrawal by Subject	6	2
Non-Compliance with Study Medication	0	2

Baseline Characteristics

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Reporting Groups

	Description
Vardenafil HCl (Levitra, BAY38-9456)	vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
Placebo	vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

Baseline Measures

	Vardenafil HCl (Levitra, BAY38-9456)	Placebo	Total
Number of Participants [units: participants]	198	198	396
Age [units: years] Mean ± Standard Deviation	55.5 ± 14.2	58.3 ± 12.8	56.9 ± 13.5
Gender ^[1] [units: participants]
Female	116	113	229
Male	82	85	167

[1]	Gender and age are given for those subjects who received treatment (Safety population).

Outcome Measures

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1. Primary:

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) ]

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2. Primary:

Change From Baseline in Average Number of Daily Micturitions at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ]

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3. Secondary:

Change From Baseline in H2O Detrusor Pressure at First Contraction at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ]

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4. Secondary:

Change From Baseline in Volume at First Detectable Leakage at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ]

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5. Secondary:

Change From Baseline in Maximum Cystometric Bladder Capacity at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ]

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6. Secondary:

Change From Baseline in Volume at First Desire to Void at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ]

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7. Secondary:

Change From Baseline in Average Number of Urgencies Per Day at 6 Weeks [ Time Frame: baseline and up to 6 weeks of treatment LOCF ]

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8. Secondary:

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 ]

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9. Secondary:

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 ]

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10. Secondary:

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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Publishing incl confidential information only after Bayer written approval. Manuscript to Bayer 60 days before submission. Confidential Information to be deleted. Other Bayer comments to be considered, if they do not alter the scientific character. If no Bayer comment within 45 days, consider approval given. If multisite study Principal Investigator (PI) not to independently publish results before publication of multisite paper, but PI not restricted from 24 months from study completion onwards.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
635 participants were screened; 238 were not randomized because they did not fulfill the inclusion/exclusion criteria. Cystometric bladder compliance not presented since only relevant to characterization of detrusor overactivity, not to efficacy.

Results Point of Contact:

Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier:	NCT00478881 History of Changes
Other Study ID Numbers:	12392, EudraCT: 2006-005145-11
Study First Received:	May 24, 2007
Results First Received:	November 16, 2009
Last Updated:	April 28, 2011
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