Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

Treatments: Drug: Placebo Matching 50 mg Udenafil; Drug: Udenafil 100 mg; Drug: Placebo Matching 100 mg Udenafil; Drug: Udenafil 50 mg; Drug: Placebo Matching 150 mg Udenafil; Drug: Udenafil 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01065012

PR-01409

Details and patient eligibility

About

Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 for the treatment of subjects with erectile dysfunction (ED).

Full description

Patients completing the double-blind phase will be entered into Study 01409 at the intermediate dose. Up and down dose adjustments will be allowed.

Enrollment: 1,027 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has completed Study PR-01209 or PR-01309
• Continues in a stable monogamous relationship with a consenting female partner who is at least 19 years of age.
• Partner is not pregnant or lactating

Exclusion criteria

• Symptomatic coronary artery disease, myocardial infarction or cardiac surgical procedure.
• Cardiac arrhythmias requiring antiarrhythmic treatment
• Symptomatic congestive heart failure
• Taking nitrate medication in any form
• Uncontrolled diabetes (HbA1c ≥ 13%)
• Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,027 participants in 4 patient groups, including a placebo group

Udenafil 50 mg

Experimental group

Description:

50 mg Udenafil

Treatment:

Drug: Placebo Matching 150 mg Udenafil

Drug: Udenafil 50 mg

Drug: Placebo Matching 100 mg Udenafil

Udenafil 100 mg

Experimental group

Description:

100 mg Udenafil

Treatment:

Drug: Placebo Matching 150 mg Udenafil

Drug: Udenafil 100 mg

Drug: Placebo Matching 50 mg Udenafil

Udenafil 150 mg

Experimental group

Description:

150 mg Udenafil

Treatment:

Drug: Udenafil 150 mg

Drug: Placebo Matching 100 mg Udenafil

Drug: Placebo Matching 50 mg Udenafil

Placebo

Placebo Comparator group

Description:

Placebo Tablets matching Udenafil tablets

Treatment:

Drug: Placebo Matching 150 mg Udenafil

Drug: Placebo Matching 100 mg Udenafil

Drug: Placebo Matching 50 mg Udenafil