Bay 38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Vardenafil (Levitra, BAY38-9456) (Drug); Vardenafil (Levitra, BAY38-9456) (Drug); Vardenafil (Levitra, BAY38-9456) (Drug); Placebo (Drug); Placebo (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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.
Clinical Details
Official title: Randomized, Double-Blind, Multi-Centre, Parallel-Goup Study to Investigate the Efficacy and Safety of Three Doses of Bay 38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15
Secondary outcome: Global Assessment QuestionnaireErectile Function domain score of the International Index of Erectile Function Safety and tolerability
Eligibility
Minimum age: 22 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Beijing 100034, China
Beijing 100044, China
Beijing 100083, China
Beijing 100853, China
Shanghai 200001, China
Shanghai 200040, China
Hangzhou, Zhejiang 310003, China
Additional Information
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Starting date: December 2002
Ending date: December 2003
Last updated: April 27, 2008
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