Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT02138825) enrolled 147 people in total — 73 received riociguat (also known as Adempas or BAY63-2521) and 74 received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring changes in how far participants could walk in six minutes — a standard test used to gauge a person's physical capacity during everyday activity — after 26 weeks of treatment. The trial also tracked clinical worsening, which was a combined measure looking at things like death from any cause, hospitalisation due to worsening heart or lung status, a significant drop in walking distance, or a decline in a standard measure of how limited a person is by their condition (WHO functional class). The reported data shows that, on average, participants in the riociguat group walked approximately 3.63 metres further at 26 weeks compared to where they started, while those in the placebo group walked approximately 15.94 metres less than where they started. Regarding clinical worsening, the reported data shows that 39 out of 73 riociguat participants and 38 out of 74 placebo participants experienced some form of clinical worsening during the study. The data also reported deaths across different phases of the study: in the riociguat group, 8 deaths occurred during the main treatment phase, 1 during a long-term extension phase, and 3 during a follow-up phase; in the placebo group, 3 deaths occurred during the main phase, 8 during the long-term extension (when those participants had switched to riociguat), 3 during follow-up, and 1 death was also recorded. Additionally, serious unwanted medical events during the safety follow-up phase were reported in 18 participants from the riociguat group and 14 from the placebo group, though what those events were is not detailed in the reported data. It is worth noting that a large proportion of participants did not complete the main study phase — 40 in the riociguat group and 35 in the placebo group — and none completed the long-term extension phase, which the trial description indicates was due to the study being terminated early; the reasons for this are not specified in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 31416769) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Pulmonary Hypertension Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 18 and 80 years old
- You have been diagnosed with, or are suspected of having, one of several specific types of idiopathic interstitial pneumonia (a group of lung conditions where the cause of scarring or inflammation is unknown) — including conditions such as idiopathic pulmonary fibrosis, cryptogenic organizing pneumonia, or similar rare lung diseases (confirm with trial site for your specific diagnosis)
- Your lungs can hold at least 45% of the normal expected amount of air (measured by a breathing test)
- In a 6-minute walking test, you can walk between 150 and 450 metres, with oxygen support through a nose tube if needed
- A special heart test (right heart catheter) has confirmed you have pulmonary hypertension, with specific pressure readings in your lungs meeting set levels (confirm with trial site)
- Your blood pressure is at a safe level (systolic reading of 95 mmHg or above) with no signs of low blood pressure
- Your overall physical ability level falls within a moderate-to-severe range as rated by a standard scale (WHO functional class II–IV)
- If you are a woman who could become pregnant, you have tested negative for pregnancy and agree to use at least two reliable forms of contraception (at least one being a physical barrier method such as condoms) throughout the study and for 4 weeks after your last dose
Who may not be able to join:
- You have significant left-side heart disease, such as blocked heart arteries causing symptoms, poor heart pumping function, or high pressure caused by fluid backing up from the heart into the lungs
- You are currently experiencing or being treated for coughing up blood or bleeding in the lungs, including if you have had a procedure to block bleeding blood vessels in the lungs
- You have had a major episode of coughing up blood, or a procedure to stop lung bleeding, within the past 3 months
- Your two 6-minute walking test results differ by more than 15% from each other
- A breathing test shows a specific airflow pattern suggesting a different type of lung condition (confirm with trial site)
- You have started certain medicines that suppress or modify the immune system — such as steroids or similar drugs — within the past 3 months
- You have received any specific treatment for pulmonary hypertension within the past 3 months
- You are currently taking nitrate medicines, nitric oxide-releasing drugs, or certain other medicines that affect blood vessel function — including sildenafil (Viagra), tadalafil, vardenafil, theophylline, or dipyridamole
- You are pregnant, breastfeeding, or are a woman who could become pregnant and are not willing or able to use adequate contraception and undergo regular pregnancy testing throughout the study and for 4 weeks after your last dose
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Bayer Study Director, Bayer
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.