NCT01553721CompletedPhase 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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 63
- Locations
- 9
- Primary Endpoint
- Phase IIb - 6-minute walk distance
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
- Phase IIa Experimental : Udenafil Dose 1, Dose 2
- Phase IIb Experimental : Udenafil
Intervention: udenafil (Drug)
placebo
Placebo Comparator
- Phase IIa Placebo Comparator : Placebo
- Phase IIb Placebo Comparator : Placebo
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Phase IIb - 6-minute walk distance
Time Frame: 16weeks
Phase IIa - Pulmonary vascular resistance index(PVRI)
Time Frame: 4 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (9)
Loading locations...
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