Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

Dong-A Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

Treatments: Drug: DA-8159 (Udenafil); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01774864

DA8159_EDD_III

Details and patient eligibility

About

Study Design : multi-center, double-blind, placebo-controlled, randomized,

parallel group, fixed dose design

Phase : Phase III

Enrollment: 349 patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients aged 20 years or more diagnosed with ED

Exclusion criteria

• Had uncontrolled blood pressure
• Had hepatic or renal dysfunction
• Was currently under anticancer chemotherapy
• Had a treatments for ED using other PDE-5 inhibitors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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349 participants in 3 patient groups, including a placebo group

DA-8159 dose 1

Experimental group

Description:

Udenafil

Treatment:

Drug: DA-8159 (Udenafil)

DA-8159 dose 2

Experimental group

Description:

Udenafil

Treatment:

Drug: DA-8159 (Udenafil)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo