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

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 III

MedlinePlus related topics:

Erectile Dysfunction High Blood Pressure

U.S. FDA Resources

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

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

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 ]

Estimated Enrollment:	112
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Placebo Comparator	Drug: Placebo Placebo as a substitute of SK3530 100mg
Group 2: Experimental	Drug: SK3530 SK3530 100 mg

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

Contacts


Contact: Jae-Seung Paick, MD,PhD	82-2-2072-2422	jspaick@snu.ac.kr

Locations


Korea, Republic of
	SK Chemicals Co., Ltd	Recruiting
	Seoul, Korea, Republic of, 135-847
	Principal Investigator: Jae-Seung Paick, MD, PhD

Sponsors and Collaborators

SK Chemicals Co.,Ltd.

Investigators


Principal Investigator:	Jae-Seung paick, MD, PhD	SNUH

More Information

Responsible Party:	SK Chemicals Co.,Ltd. ( Don-Yong Chang/SK Chemicals Co.,Ltd. )
Study ID Numbers:	SK3530_HTN_III
First Received:	March 23, 2008
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00644007
Health Authority:	Korea: Food and Drug Administration

Keywords provided by SK Chemicals Co.,Ltd.:

Erectile dysfunction

Hypertension

SK3530

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological

Sexual Dysfunction, Physiological

Mental Disorders

Genital Diseases, Male

Erectile Dysfunction

Hypertension

Additional relevant MeSH terms:

Sexual and Gender Disorders

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	SK Chemicals Co.,Ltd.
Information provided by:	SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT00644007