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Therapeutic Areas: Nephrology/Urology
Disease Category: Erectile Dysfunction

Trial Information

A randomized, placebo-controlled double-blind paraller design phase 3 study to assess the safety and efficacy of wc3043 tablets in male subjects with erectile dysfunction.

This is a randomized, placebo-controlled, double-blind parallel design phase 3 study to evaluate the safety and efficacy of wc3043 an orally administered potent and selective inhibitor of pde-5 versus placebo for the treatment of subjects with erectile dysfunction. This study will be a pivotal safety and efficacy study.

Inclusion Criteria

• He has a stable momogamous relationship for at least 6 months.
• He has signed an appropriately administered informed consent.
• He has completed at least four diary entries by visit 1a.
• His partner is not pregnant or lactating.

Exclusion Criteria

• He has cardiac arrhythmias requiring antiarrhythmic treatment.
• has a prolonged QTC on the ecg at visit 1
• has symptomatic congestive heart failure
• has uncontrolled diabetes
• has a history of spinal cord injury
• has significant hepatic enzyme elevation

Well Pharma Medical Research, Corp.
7000 SW 62 Avenue Suite 405
Miami, FL 33143
Phone: 305-665-4813

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