Phase III Study to Assess the Efficacy and Safety of SK3530 in Patients With Erectile Dysfunction and Hypertension

SK chemicals

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

Treatments: Drug: Placebo; Drug: SK3530

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644007

SK3530_HTN_III

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of SK3530 in men with ED and hypertension who were taking antihypertensive medication.

Full description

SK3530 is a potent and selective phosphdiesterase type 5(PDE 5) inhibitor developed for the treatment of erectile dysfunction(ED). Since ED is common in men with hypertension, it is important to determine the efficacy and safety of SK3530 in men with ED taking antihypertensive medication.

Enrollment: 109 patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypertension patient taking stable hypertensive medication for at least 4 weeks
• Score below 25 from IIEF EF domain during 4 weeks of treatment run-in period
• Failure rate above 50% from sexual attempt above 4 during 4 weeks of treatment run-in period

Exclusion criteria

• Lab abnormality
• Uncontrolled diabetic mellitus
• High or low blood pressure, orthostatic hypotension
• Hyper- or hypo-thyroidism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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109 participants in 2 patient groups, including a placebo group

Group 1

Placebo Comparator group

Treatment:

Drug: Placebo

Group 2

Experimental group

Treatment:

Drug: SK3530