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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 April 2016 |
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Main ID: |
NCT01553721 |
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Date of registration:
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01/01/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
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Scientific title:
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A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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63 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01553721 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Duk-Kyung Kim, M.D., Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Samsung Medical Center, 50 Irwon-Dong, Gangnam-Gu, Special city of Seoul, 135-710, Korea |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: placebo
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Drug: udenafil
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Primary Outcome(s)
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Phase IIa - Pulmonary vascular resistance index(PVRI)
[Time Frame: 4 hours]
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Phase IIb - 6-minute walk distance
[Time Frame: 16weeks]
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Secondary ID(s)
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DA8159_PAH_II
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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