To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00661115
First received: April 15, 2008
Last updated: June 19, 2009
Last verified: June 2009
| Tracking Information | |||||
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| First Received Date ICMJE | April 15, 2008 | ||||
| Last Updated Date | June 19, 2009 | ||||
| Start Date ICMJE | May 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15 [ Time Frame: At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00661115 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction. | ||||
| Official Title ICMJE | A Randomised, Double Blind, Placebo Controlled, Multi-Center, Fixed Dose, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil (BAY 38-9456) in Men With Erectile Dysfunction . | ||||
| Brief Summary | To investigate the efficacy and safety of vardenafil in men with erectile dysfunction. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Erectile Dysfunction | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 193 | ||||
| Completion Date | February 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | India | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00661115 | ||||
| Other Study ID Numbers ICMJE | 10695 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Therapeutic Area Head, Bayer HealthCare AG | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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