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

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo
SK3530
Sponsored by
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction, Hypertension, SK3530

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • SK Chemicals Co., Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Group 1

Group 2

Arm Description

Outcomes

Primary Outcome Measures

Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire

Secondary Outcome Measures

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)

Full Information

First Posted
March 23, 2008
Last Updated
April 16, 2013
Sponsor
SK Chemicals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00644007
Brief Title
Phase III Study to Assess the Efficacy and Safety of SK3530 in Patients With Erectile Dysfunction and Hypertension
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile dysfunction, Hypertension, SK3530

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Title
Group 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo as a substitute of SK3530 100mg
Intervention Type
Drug
Intervention Name(s)
SK3530
Other Intervention Name(s)
Mvix
Intervention Description
SK3530 100 mg
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Seung paick, MD, PhD
Organizational Affiliation
SNUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
SK Chemicals Co., Ltd
City
Seoul
ZIP/Postal Code
135-847
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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