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

Sponsor
SK Chemicals Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT00644007
Collaborator
(none)
109
Enrollment
1
Location
2
Arms
12
Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
109 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Group 1

Drug: Placebo
Placebo as a substitute of SK3530 100mg
Experimental: Group 2

Drug: SK3530
SK3530 100 mg
Other Names:
  • Mvix

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire [0, 4, 8, 12 week]

    Secondary Outcome Measures

    1. 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) [0, 4, 8, 12 W]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SK Chemicals Co., Ltd Seoul Korea, Republic of 135-847

    Sponsors and Collaborators

    • SK Chemicals Co., Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SK Chemicals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT00644007
    Other Study ID Numbers:
    • SK3530_HTN_III
    First Posted:
    Mar 26, 2008
    Last Update Posted:
    Apr 18, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by SK Chemicals Co., Ltd.
    Erectile dysfunction
    Hypertension
    SK3530
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of Apr 18, 2013