BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00668057
First received: April 24, 2008
Last updated: March 8, 2010
Last verified: March 2010
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Purpose
This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction |
Drug: Vardenafil (Levitra, BAY38-9456) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction |
Resource links provided by NLM:
MedlinePlus related topics:
Erectile Dysfunction
Drug Information available for:
Vardenafil
Vardenafil hydrochloride
Vardenafil dihydrochloride
Vardenafil hydrochloride trihydrate
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Global Assessment Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Erectile Function domain score of the International Index of Erectile Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 480 |
| Study Start Date: | December 2002 |
| Study Completion Date: | December 2003 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Vardenafil (Levitra, BAY38-9456)
5 mg Vardenafil orally 1 hour prior to sexual intercourse
|
| Experimental: Arm 2 |
Drug: Vardenafil (Levitra, BAY38-9456)
10 mg Vardenafil orally 1 hour prior to sexual intercourse
|
| Experimental: Arm 3 |
Drug: Vardenafil (Levitra, BAY38-9456)
20 mg Vardenafil orally 1 hour prior to sexual intercourse
|
| Placebo Comparator: Arm 4 |
Drug: Placebo
5 mg matching placebo
|
| Placebo Comparator: Arm 5 |
Drug: Placebo
10 mg matching placebo
|
| Placebo Comparator: Arm 6 |
Drug: Placebo
20 mg matching placebo
|
Eligibility| Ages Eligible for Study: | 22 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
- Stable heterosexual relationship
Exclusion Criteria:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
- Nitrate use
- Other exclusion criteria apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668057
Locations
| China, Zhejiang | |
| Hangzhou, Zhejiang, China, 310003 | |
| China | |
| Beijing, China, 100034 | |
| Beijing, China, 100044 | |
| Beijing, China, 100083 | |
| Beijing, China, 100853 | |
| Shanghai, China, 200040 | |
| Shanghai, China, 200127 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00668057 History of Changes |
| Other Study ID Numbers: | 10690 |
| Study First Received: | April 24, 2008 |
| Last Updated: | March 8, 2010 |
| Health Authority: | China: Food and Drug Administration United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Male Erectile Dysfunction |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Vardenafil Vasodilator Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013