To evaluate the efficacy and safety of 26-weeks of treatment with riociguat vs. placebo in patients with symptomatic PH (pulmonary hypertension) associated with IIP (idiopathic interstitial pneumonias).
Number of participants with Adverse Events (AEs) will be reported in Adverse Events section.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
147
Active drug 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration. The starting dose will be 0.5 mg TID, and the dose will be adjusted every two weeks for ten weeks in 0.5 mg increments up to a maximum dose of 2.5 mg TID based on patient's systolic blood pressure and well-being.
Inactive dosed at 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration for 26 weeks
Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26
The 6MWD test is designed to evaluate a patient's exercise capacity while performing an everyday activity.
Time frame: Baseline to 26 weeks
Number of Participants With Clinical Worsening
The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; need for hospitalization due to worsening cardiopulmonary (CP) status, attributable to progression of disease (including but not limited to increased shortness of breath or increased leg swelling); \>15% decrease in the 6MWD test; worsening of WHO functional class.
Time frame: From baseline to week 26
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University of California, Los Angeles
Los Angeles, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orlando, Florida, United States
Via Christi Clinic
Wichita, Kansas, United States
Unnamed facility
Louisville, Kentucky, United States
Columbia University Medical Center
New York, New York, United States
Unnamed facility
Durham, North Carolina, United States
Unnamed facility
Cincinnati, Ohio, United States
...and 83 more locations