Status:
COMPLETED
Phase III Study to Assess the Efficacy and Safety of SK3530 in Patients With Erectile Dysfunction and Hypertension
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Erectile Dysfunction
Eligibility:
MALE
19+ years
Phase:
PHASE3
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 deter...
Eligibility Criteria
Inclusion
- 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
- Lab abnormality
- Uncontrolled diabetic mellitus
- High or low blood pressure, orthostatic hypotension
- Hyper- or hypo-thyroidism
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00644007
Start Date
December 1 2007
End Date
December 1 2008
Last Update
April 18 2013
Active Locations (1)
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1
SK Chemicals Co., Ltd
Seoul, South Korea, 135-847