Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

April 15, 2016 updated by: Dong-A ST Co., Ltd.

A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

This is a placebo-controlled, double-blind, phase II clinical study to evaluate the efficacy and safety of Udenafil in patient with Pulmonary Arterial Hypertension(PAH).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Chung-ju, Korea, Republic of
        • Chungbook National University Hospital
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • Gwang-ju, Korea, Republic of
        • Chonnam National University Hospital
      • Pusan, Korea, Republic of
        • Pusan National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
    • Chongno-gu, 28 Yongon-dong
      • Seoul, Chongno-gu, 28 Yongon-dong, Korea, Republic of, 110-744
        • Seoul National University Hospital
    • Gangnam-Gu, Irwon-Dong 50
      • Seoul, Gangnam-Gu, Irwon-Dong 50, Korea, Republic of, 135-710
        • Samsung Medical Center
    • Seodaemungu, 250 Seonsanno
      • Special City of Seoul, Seodaemungu, 250 Seonsanno, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Subjects aged 18 and over who have any of the following diseases

  • primary Pulmonary Arterial Hypertension
  • secondary Pulmonary Arterial Hypertension caused by connective tissue disease
  • [Phase IIb] Pulmonary Arterial Hypertension caused by congenital heart disease(including Eisenmenger syndrome)

Exclusion Criteria:

  • Subjects with pulmonary arterial hypertension caused by any etiology other than those specified in the inclusion criteria
  • BMI(Body Mass Index) < 18.5kg/m2
  • Subjects with hypotension(SBP/DBP<90/50mmHg) or uncontrolled hypertension(SBP/DBP>170/100mmHg)
  • Creatinine clearance ≤ 30mL/min
  • History of non-arteritic anterior ischemic optic neuropathy(NAION)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: udenafil
  1. Phase IIa Experimental : Udenafil Dose 1, Dose 2
  2. Phase IIb Experimental : Udenafil
Drug: udenafil

Phase IIa - Udenafil Dose 1, Dose 2(Single dose)

Phase IIb - Udenafil(BID)
Placebo Comparator: placebo
  1. Phase IIa Placebo Comparator : Placebo
  2. Phase IIb Placebo Comparator : Placebo
Drug: placebo
Phase IIa - placebo Phase IIb - placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase IIa - Pulmonary vascular resistance index(PVRI)
Time Frame: 4 hours
4 hours
Phase IIb - 6-minute walk distance
Time Frame: 16weeks
16weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • Principal Investigator: Duk-Kyung Kim, M.D., Ph.D, Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 1, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA8159_PAH_II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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