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

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ClinicalTrials.gov Identifier: NCT00644007
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : April 18, 2013
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.

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
Erectile Dysfunction Drug: Placebo Drug: SK3530 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 Type : Interventional  (Clinical Trial)
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 : December 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


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 Name: Mvix




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 [ Time Frame: 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) [ Time Frame: 0, 4, 8, 12 W ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00644007     History of Changes
Other Study ID Numbers: SK3530_HTN_III
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: April 18, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders