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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SK Chemicals Co., Ltd.; SK Chemicals Co.,Ltd.

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