NCT01553721
Completed
Phase 2
A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)
Overview
- Phase
- Phase 2
- Intervention
- udenafil
- Conditions
- Pulmonary Arterial Hypertension
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 63
- Locations
- 9
- Primary Endpoint
- Phase IIb - 6-minute walk distance
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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).
Investigators
Eligibility 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)
Arms & Interventions
udenafil
1. Phase IIa Experimental : Udenafil Dose 1, Dose 2 2. Phase IIb Experimental : Udenafil
Intervention: udenafil
placebo
1. Phase IIa Placebo Comparator : Placebo 2. Phase IIb Placebo Comparator : Placebo
Intervention: placebo
Outcomes
Primary Outcomes
Phase IIb - 6-minute walk distance
Time Frame: 16weeks
Phase IIa - Pulmonary vascular resistance index(PVRI)
Time Frame: 4 hours
Study Sites (9)
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