TerminatedPhase 2

Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)

Stopped: Study terminated per recommendation of iDMC. On iDMC request, protocol amended to include 4-month safety follow-up for patients after withdrawal of riociguat.

United States, Argentina, Australia147 participantsStarted 2014-06-04

Plain-language 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).

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* Inclusion Criteria: * Men or women aged from ≥18 to ≤80 years * Diagnosed with one of the following (confirmed using a multidisciplinary approach, as per ATS(American Thoracic Society) / ERS(European Respiratory Society) / JRS (Japanese Respiratory Society) / ALAT(Latin American Thoracic Association) guidelines: * Major IIPs (idiopathic interstitial pneumonias) diagnosis or suspected as one of the following: * Idiopathic pulmonary fibrosis * Idiopathic nonspecific interstitial pneumonia * Respiratory bronchiolitis-interstitial lung disease * Desquamative interstitial pneumonia * Cryptogenic organizing pneumonia * Acute interstitial pneumonia * Rare IIPs diagnosis by one of the following: * Idiopathic lymphoid interstitial pneumonia * Idiopathic pleuroparenchymal fibroelastosis * Unclassifiable idiopathic interstitial pneumonias * Forced Vital Capacity (FVC) ≥ 45 % * 6MWD (6 minutes walking distance) ≥ 150 m to ≤ 450 m {under stable O2(oxygen) supplementation via nasal cannula} * Diagnosis of PH (pulmonary hypertension) confirmed by right heart catheter (RHC) with (mean artery pulmonary artery pressure )mPAP ≥ 25 mmHg and (pulmonary artery wedge pressure)PAWP ≤15 mmHg at rest * Systolic blood pressure (SBP) ≥ 95 mmHg and no signs or symptoms of hypotension * WHO functional class II-IV * Women of childbearing potential can only be included in the study if a pregnancy test is negative. Women of childbearing potential must agree to use adequate contracept…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26

Timeframe: Baseline to 26 weeks

Trial details

NCT IDNCT02138825

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-05-05

Results submitted2017-05-03

View on ClinicalTrials.gov More Idiopathic Interstitial Pneumonias / Hypertension,Pulmonary trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.