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NCT01553721 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01553721
Other study ID # DA8159_PAH_II
Secondary ID
Status Completed
Phase Phase 2
First received January 1, 2012
Last updated April 15, 2016
Start date August 2011
Est. completion date March 2015

Study information
Verified date April 2016
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority South Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 63
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• udenafil
Phase IIa - Udenafil Dose 1, Dose 2(Single dose) Phase IIb - Udenafil(BID)
• placebo
Phase IIa - placebo Phase IIb - placebo

Locations
Country Name City State
Korea, Republic of Chungbook national University Hospital Chung-ju
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of Chonnam National University Hospital Gwang-ju
Korea, Republic of Pusan national University Hospital Pusan
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul Gangnam-Gu, Irwon-Dong 50
Korea, Republic of Seoul National University Hospital Seoul Chongno-gu, 28 Yongon-dong
Korea, Republic of The catholic univ. of korea Seoul ST. MARY's hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Special City of Seoul Seodaemungu, 250 Seonsanno

Sponsors (1)
Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Phase IIa - Pulmonary vascular resistance index(PVRI) 4 hours No
Primary Phase IIb - 6-minute walk distance 16weeks No
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