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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00644007
First received: March 23, 2008
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Erectile Dysfunction
 Drug: Placebo
Drug: SK3530
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by SK Chemicals Co.,Ltd.:

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 [ Time Frame: 0, 4, 8, 12 week ] [ Designated as safety issue: Yes ]

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) [ Time Frame: 0, 4, 8, 12 W ] [ Designated as safety issue: Yes ]

Enrollment: 109
Study Start Date: December 2007
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group 1 Drug: Placebo
Placebo as a substitute of SK3530 100mg
Other Name: Placebo
Experimental: Group 2 Drug: SK3530
SK3530 100 mg
Other Name: Mvix

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644007

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00644007     History of Changes
Other Study ID Numbers: SK3530_HTN_III
Study First Received: March 23, 2008
Last Updated: April 16, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by SK Chemicals Co.,Ltd.:
Erectile dysfunction
Hypertension
SK3530

Additional relevant MeSH terms:
Hypertension
Erectile Dysfunction
Vascular Diseases
Cardiovascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
 Sexual and Gender Disorders
Mental Disorders
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013