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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644007
• Other study ID #: SK3530_HTN_III
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2008
• Last updated: April 16, 2013
• Start date: December 2007
• Est. completion date: December 2008

Study information

• Verified date: April 2013
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Placebo
Placebo as a substitute of SK3530 100mg
• SK3530
SK3530 100 mg

Locations

Country	Name	City	State
Korea, Republic of	SK Chemicals Co., Ltd	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire		0, 4, 8, 12 week	Yes
Secondary	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)		0, 4, 8, 12 W	Yes