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

April 16, 2013 updated by: SK Chemicals Co., Ltd.

A Double Blind, Randomized, Placebo-controlled, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy and Safety of SK3530 in Patients With Erectile Dysfunction Taking Antihypertensive Medication

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2
Drug: SK3530
SK3530 100 mg
Other Names:
  • Mvix
Placebo Comparator: Group 1
Drug: Placebo
Placebo as a substitute of SK3530 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire
Time Frame: 0, 4, 8, 12 week
0, 4, 8, 12 week

Secondary Outcome Measures

Outcome Measure
Time Frame
the score from : 1) IIEF Q3 & Q4, 2) other domains of IIEF, 3) Sexual Encounter Profile(SEP)Q2 and Q3, 4) Life Satisfaction Checklist, 5) Global Efficacy Assessment Question(GEAQ)
Time Frame: 0, 4, 8, 12 W
0, 4, 8, 12 W

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Chemicals Co., Ltd.

Investigators

  • Principal Investigator: Jae-Seung paick, MD, PhD, SNUH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 23, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

April 18, 2013

Last Update Submitted That Met QC Criteria

April 16, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SK3530_HTN_III

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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