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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo as a substitute of SK3530 100mg

Group 2

Group Type EXPERIMENTAL

SK3530

Intervention Type DRUG

SK3530 100 mg

Interventions

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Placebo

Placebo as a substitute of SK3530 100mg

Intervention Type DRUG

SK3530

SK3530 100 mg

Intervention Type DRUG

Other Intervention Names

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Mvix

Eligibility Criteria

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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