BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
Phase 3
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00668057
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 624
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 3 Levitra (Vardenafil, BAY38-9456) - Arm 4 Placebo - Arm 6 Placebo - Arm 1 Levitra (Vardenafil, BAY38-9456) - Arm 5 Placebo - Arm 2 Levitra (Vardenafil, BAY38-9456) -
- Primary Outcome Measures
Name Time Method Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15 12 weeks
- Secondary Outcome Measures
Name Time Method Safety and tolerability 12 weeks Erectile Function domain score of the International Index of Erectile Function 12 weeks Global Assessment Questionnaire 12 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie vardenafil's PDE5 inhibition in Chinese ED patients per NCT00668057?
How does vardenafil's efficacy compare to standard-of-care PDE5 inhibitors like sildenafil in Chinese ED populations?
Are there biomarkers in NCT00668057 data predicting response to vardenafil 5/10/20 mg in ED treatment?
What adverse event profiles distinguish vardenafil from placebo in NCT00668057's 12-week ED trial?
How do vardenafil's pharmacokinetics in Chinese patients relate to competitor drugs like tadalafil for ED?