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Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

W

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)

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

Trial contacts and locations

72

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Data sourced from clinicaltrials.gov

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