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 (NCT00367770) enrolled 37 people, all of whom received a treatment called Tracleer (bosentan). The trial was looking at how participants' physical condition changed over 24 weeks, specifically measuring how far they could walk in six minutes, how breathless they felt during effort (using a numbered scale), and whether their overall disease classification assigned by a doctor changed over that period. Thirty-five of the 37 participants completed the trial, and two did not finish. The reported data shows the following results after 24 weeks. On average, participants' six-minute walk distance changed by 13.5 metres. Their score on the Borg Dyspnoea Index — a scale from 0 (no breathlessness) to 10 (maximum breathlessness) used to rate how hard it feels to breathe — changed by an average of 0.1 units. For the third measure, 13 out of 37 participants were reported to have had a change in their WHO Functional Class (a doctor-assigned rating of how much a condition limits daily activities) from their starting point to week 24. The reported data does not break down how many of those 13 people improved versus worsened, only that a change occurred. No comparison group (such as a placebo group) was included in the data submitted, so these figures reflect the Tracleer group alone. 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 ↗
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 4 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:
- You completed the full 16-week BREATHE-5 clinical study (study code AC-052-405) and your pulmonary arterial hypertension (a type of high blood pressure in the lungs) was stable at the end of it.
- If you are a woman, you are either not pregnant and cannot become pregnant (due to surgery, being past menopause, or documented infertility), or you are using an approved form of contraception such as a barrier method (like a condom or diaphragm) combined with spermicide, an IUD, or the pill/implant used together with a barrier method.
- You are willing and able to sign a written consent form agreeing to take part in the trial.
Who may not be able to join:
- You left the earlier BREATHE-5 study early, before it was completed.
- You are currently pregnant or breastfeeding.
- You are currently taking, or are expected to take, epoprostenol or similar medications called prostacyclin analogues during the study.
- Your liver enzyme levels (AST and/or ALT) are more than 3 times higher than the normal range.
- Your red blood cell count (hemoglobin or hematocrit) is more than 30% lower than the normal range (note: people with a condition causing too many red blood cells may still be eligible — confirm with trial site).
- Your systolic blood pressure (the top number in a blood pressure reading) is below 85 mmHg.
- You are currently taking certain other medications, including phosphodiesterase inhibitors, other endothelin receptor antagonists, or any other experimental treatment.
- You are currently on a waiting list for an organ transplant.
- You are taking or expected to take glyburide, cyclosporin A, or tacrolimus during the study.
- You are unable or unwilling to follow the study rules and take the medication as required.
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: Michael Landzberg, MD, BACH Pulmonary Hypertension Service, Boston, U.S.A.
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
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change in 6-minute Walk Distance; Change in Borg Dyspnea Index; Number of Participants With a Change in WHO Functional Class
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.