BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Vardenafil (Levitra, BAY38-9456)
- 5 mg Vardenafil orally 1 hour prior to sexual intercourse
- Drug: Vardenafil (Levitra, BAY38-9456)
- 10 mg Vardenafil orally 1 hour prior to sexual intercourse
- Drug: Vardenafil (Levitra, BAY38-9456)
- 20 mg Vardenafil orally 1 hour prior to sexual intercourse
- Drug: Placebo
- 5 mg matching placebo
- Drug: Placebo
- 10 mg matching placebo
- Drug: Placebo
- 20 mg matching placebo
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Arm 1
- Experimental: Arm 2
- Experimental: Arm 3
- Placebo Comparator: Arm 4
- Placebo Comparator: Arm 5
- Placebo Comparator: Arm 6
Outcome Measures for this Clinical Trial
Primary Measures
- Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
Secondary Measures
- Global Assessment Questionnaire
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
- Erectile Function domain score of the International Index of Erectile Function
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
- Safety and tolerability
- Time Frame: 12 weeks
Safety Issue?: Yes
- Time Frame: 12 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 22 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Bayer Industry
Overall Clinical Trial Officials and Contacts
Bayer Study Director Study Director Bayer
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668057
Study ID Number: 10690
ClinicalTrials.gov Identifier: NCT00668057
Health Authority: China: State Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00668057
