Clinical Trial: Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomized, Double-blind, Placebo-controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat (0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID) in Patients With Symptomatic Pulmonary
Brief Summary: 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).
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: The mean change in 6 minute walking distance [ Time Frame: Baseline to 26 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to clinical worsening is a composite endpoint. The composite is made up of 4 components - Time to all-cause mortality, - Time to worsening of WHO FC, - Time to 15% decrease in 6MWD, - Time to hospitalization [ Time Frame: Up to week 26 ]
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 9 years ]
Original Secondary Outcome:
- Time to clinical worsening is a composite endpoint. The composite is made up of 4 components - Time to all-cause mortality, - Time to worsening of WHO FC, - Time to 15% decrease in 6MWD, - Time to hospitalization [ Time Frame: Up to week 26 ]
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 6 years ]
Information By: Bayer
Dates:
Date Received: April 15, 2014
Date Started: June 2014
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016
