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

Tracking Information

First Received Date ^ICMJE

March 23, 2008

Last Updated Date

March 25, 2008

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00644007 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Erectile Dysfunction

Intervention ^ICMJE

Drug: Placebo
Drug: SK3530

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

112

Estimated Completion Date

December 2008

Estimated Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jae-Seung Paick, MD,PhD

82-2-2072-2422

jspaick@snu.ac.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00644007

Responsible Party

Don-Yong Chang/SK Chemicals Co.,Ltd., SK Chemicals Co.,Ltd.

Study ID Numbers ^ICMJE

SK3530_HTN_III

Study Sponsor ^ICMJE

SK Chemicals Co.,Ltd.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jae-Seung paick, MD, PhD

SNUH

Information Provided By

SK Chemicals Co.,Ltd.

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP