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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01553721
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: udenafil Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : August 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Phase IIa - Pulmonary vascular resistance index(PVRI) [ Time Frame: 4 hours ]
  2. Phase IIb - 6-minute walk distance [ Time Frame: 16weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553721


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Chongno-gu, 28 Yongon-dong, Korea, Republic of, 110-744
Samsung Medical Center
Seoul, Gangnam-Gu, Irwon-Dong 50, Korea, Republic of, 135-710
Severance Hospital, Yonsei University Health System
Special City of Seoul, Seodaemungu, 250 Seonsanno, Korea, Republic of, 120-752
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
The catholic univ. of korea Seoul ST. MARY's hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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Principal Investigator: Duk-Kyung Kim, M.D., Ph.D Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01553721    
Other Study ID Numbers: DA8159_PAH_II
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
 Respiratory Tract Diseases
Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action