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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00644007

Enrollment

109

Registered

2008-03-26

Start date

2007-12-31

Completion date

2008-12-31

Last updated

2013-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction, Hypertension, SK3530

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.

Interventions

DRUGPlacebo

Placebo as a substitute of SK3530 100mg

DRUGSK3530

SK3530 100 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026