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 enrolled 445 people in total across three groups: 254 received riociguat (Adempas) at a dose of up to 2.5 mg, 64 received riociguat at a lower dose of up to 1.5 mg, and 127 received a placebo (a dummy treatment with no active ingredient). The trial was studying a condition called pulmonary arterial hypertension — high blood pressure in the arteries of the lungs — and ran for 12 weeks. The main thing being measured was how far participants could walk in six minutes, which is a standard way of gauging a person's physical capacity. A number of other things were also tracked, including blood pressure resistance in the lung arteries, a heart-stress marker in the blood, how participants rated their own breathlessness during exercise, and how many people experienced a significant health setback during the trial. The reported data shows that, for the primary measure — change in six-minute walking distance from the start to week 12 — the higher-dose riociguat group recorded an average increase of about 30 metres, the lower-dose group recorded an average increase of about 31 metres, and the placebo group recorded an average decrease of about 6 metres. For the secondary measures, the reported data shows that lung artery resistance (a technical measure of how hard the heart must work to push blood through the lungs) changed by an average of −223 units in the higher-dose group, −168 units in the lower-dose group, and −9 units in the placebo group — where a lower number means less resistance. A blood marker linked to heart stress (NT-proBNP) changed by an average of −198 units in the higher-dose group, −472 units in the lower-dose group, and increased by +232 units in the placebo group. On a scale of 0–10 measuring how hard participants felt they were breathing during exercise (the Borg scale), the higher-dose group reported a change of −0.44, the lower-dose group −0.33, and the placebo group +0.09. Regarding significant health setbacks during the trial, the reported data shows that 1.2% of the higher-dose group, 3.2% of the lower-dose group, and 6.3% of the placebo group experienced what was classed as clinical worsening overall, though the data was broken down across several sub-categories. Functional class (a doctor's rating of how limited a person is by their condition) data was also reported across categories, but the individual category breakdowns are complex and the overall pattern across groups was not summarised as a single figure. 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 23883383) ↗
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 3 Pulmonary Hypertension Trial, Completed
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:
- Men and women who have been diagnosed with pulmonary arterial hypertension (high blood pressure in the lungs) that is causing symptoms, including types caused by unknown reasons, family history, connective tissue diseases, certain heart defects present from birth, high pressure in the liver's blood vessels (portal hypertension with liver cirrhosis), or past use of certain weight-loss drugs or amphetamines
- People who have never been treated for this condition before, as well as those who have already been treated with certain types of medications called endothelin antagonists or prostacyclin analogues (but not the type given directly into a vein)
Who may not be able to join:
- People who have other types of pulmonary hypertension (high blood pressure in the lungs) that are not listed in the inclusion criteria above
- People who have severe COPD (a serious long-term lung condition that makes it hard to breathe)
- People whose high blood pressure (in the body generally, not just the lungs) is not well controlled
- People who have heart failure on the left side of the heart
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
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.