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Clinical Trial Summary

Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).


Clinical Trial Description

Multi-center, randomized, double-blind, placebo-controlled, parallel-group design, Phase 3 pivotal study to investigate the efficacay and safety of 50 mg, 100 mg and 150 mg udenafil tablets compared with placebo in men with ED. This study consisted of a 4-week, treatment free run-in period followed by a treatment period of 12 weeks, with an on-demand dosing regimen. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01037218
Study type Interventional
Source Warner Chilcott
Contact
Status Completed
Phase Phase 3
Start date September 2009
Completion date April 2010

See also
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