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

Dong-A Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

Treatments: Drug: DA-8159 (Udenafil)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01901640

DA8159_EDDL_III

Details and patient eligibility

About

Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159_EDD_III)

Full description

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.

Enrollment: 302 patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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302 participants in 1 patient group

DA-8159

Experimental group

Description:

Udenafil(The study had one arm.)

Treatment:

Drug: DA-8159 (Udenafil)