To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
130
oral, 20 mg, tid
oral 1 mg, tid
oral 5 mg, tid
Change From Baseline in the Total Distance Walked During 6-Minute Walk Test (6MWT) at Week 12
6 MWT was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety.
Time frame: Baseline and Week 12
Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Week 12
mPAP was measured using a pressure transducer positioned at the mid-axillary line.
Time frame: Baseline and Week 12
Number of Participants With Clinical Worsening
Clinical worsening was defined as death; or lung transplantation; or hospitalization due to pulmonary hypertension; or initiation of prostacyclin therapy; or initiation of endothelin receptor antagonist therapy. (PAH=pulmonary arterial hypertension) Due to very low number of events of clinical worsening reported, the median days to clinical worsening could not be estimated.
Time frame: Baseline through Week 12
Number of Participants With Change From Baseline in PAH Criteria for Functional Capacity and Therapeutic Class at Week 12
Pulmonary arterial hypertension (PAH) Criteria for WHO Class: Class I (Participants without resulting limitation of physical activity);Class II (Participants with slight limitation of physical activity though comfortable at rest);Class III (Participants with marked limitation of physical activity,though comfortable at rest);Class IV(Participants with inability to carry out any physical activity without symptoms,manifest signs of right heart failure; dyspnoea and/or fatigue may even be present at rest; and discomfort is increased by any physical activity).
Time frame: Baseline and Week 12
Change From Baseline in B-Type Natriuretic Peptide (BNP) at Week 12
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oral 20 mg, tid
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, United States
Medical College of Georgia
Augusta, Georgia, United States
Atlanta Institute for Medical Research, Inc.
Decatur, Georgia, United States
Chicago Heart Institute
Elk Grove Village, Illinois, United States
The Care Group, LLC
Indianapolis, Indiana, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Mid Carolina Cardiology
Charlotte, North Carolina, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Baylor College of Medicine Pulmonary Section
Houston, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
...and 36 more locations
BNP is a non-invasive biomarker and an indicator of progression of PAH/ right ventricular dysfunction in participants with PAH.
Time frame: Baseline and Week 12
Change From Baseline in Pro-BNP at Week 12
Pro- BNP which is a precursor of BNP, is a non-invasive biomarker and an indicator of progression of PAH / RV dysfunction in participants with PAH.
Time frame: Baseline and Week 12
Change From Baseline in TAPSE Measurement at Week 12
Tricuspid annular plane systolic excursion (TAPSE) was measured as the total displacement of the tricuspid annulus in cm from end diastole to end systole.TAPSE is an indicator of progression of PAH /right ventricular dysfunction. The baseline data for 33 participants were measured incorrectly and the results from the 33 participants (both baseline and post-baseline) were excluded from the analysis.
Time frame: Baseline and Week 12
Change From Baseline in BORG Dyspnoea Score at Week 12
BORG dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 0 (no breathlessness at all); 0.5 (very very slight \[just noticeable\]); 1 (very slight); 2 (slight breathlessness); 3 (moderate); 4 (some what severe); 5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe \[almost maximum\] and 10 (maximum).
Time frame: Baseline and Week 12