Phase III Study to Assess the Efficacy and Safety of SK3530 in Patients With Erectile Dysfunction and Hypertension
- Registration Number
- NCT00644007
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 109
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Placebo - Group 2 SK3530 -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
SK Chemicals Co., Ltd
🇰🇷Seoul, Korea, Republic of