Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction

Phase 3CompletedNCT01901640

Dong-A Pharmaceutical Co., Ltd.302 enrolled

Overview

Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159\_EDD\_III)

Completer from parent study(DA8159\_EDD\_III)continued into a 24weeks open-label extension during which they received udenafil once daily. The study concluded with a 4-week ED treatment-free period.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

302

Conditions

Erectile Dysfunction

Interventions

DA-8159 (Udenafil)DRUG

Eligibility

Sex: MALEMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male patients aged 20 years or more diagnosed with erectile dysfunction(ED) Exclusion Criteria: * Had uncontrolled blood pressure * Had hepatic or renal dysfunction * Had significant psychiatric disorders or drug abuses * Was currently under anticancer chemotherapy * Had a treatments for ED using other phosphodiesterase type 5(PDE-5) inhibitors

Outcomes

Primary Outcomes

Safety

Safety evaluation included adverse events, standard 12-lead electrocardiograms and clinical laboratory measures. The AEs measured as percentage and number of patients.

Time frame: 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)

Secondary Outcomes

International Index of Erectile Function(IIEF), GAQ(Global Assessment Questions), Shift to normal

The efficacy measures(Unit of Measure) * IIEF EF domain score(Change from baseline) * IIEF other domain scores(Change from baseline) * GAQ \& Shift to normal(percentage of subject)

Time frame: 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study)

Data from ClinicalTrials.gov

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