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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.
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd. Identifier:
First received: March 23, 2008
Last updated: April 16, 2013
Last verified: April 2013
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
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

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 ]

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 ]

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
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.

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00644007

Korea, Republic of
SK Chemicals Co., Ltd
Seoul, Korea, Republic of, 135-847
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Principal Investigator: Jae-Seung paick, MD, PhD SNUH
  More Information

Responsible Party: SK Chemicals Co.,Ltd. Identifier: NCT00644007     History of Changes
Other Study ID Numbers: SK3530_HTN_III
Study First Received: March 23, 2008
Last Updated: April 16, 2013

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

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders processed this record on May 22, 2017