Phase 3 Pulmonary Hypertension Trial, Completed NCT00380068 Sponsor: Gilead Sciences Condition: Pulmonary Hypertension
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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 224 people, all of whom received a medicine called ambrisentan. There was no comparison group. Of the 224 who started, 155 completed the trial and 69 did not finish. The trial was measuring several things over 24 and 48 weeks, including how far participants could walk in six minutes, how breathless they felt during exertion, a blood marker related to heart stress (called BNP), and their overall physical function category as rated by the World Health Organization (WHO). The reported data shows that, on average, participants walked about 20.5 metres further at 24 weeks compared to when they started. For breathlessness — measured on a 0-to-10 scale where 0 means no breathlessness and 10 means maximum — the average score changed by minus 0.5 points at 24 weeks and minus 0.6 points at 48 weeks. The BNP blood marker (a measure related to heart stress) showed a reported average decrease of 25.5% at 24 weeks and 29.2% at 48 weeks. For the WHO physical function category at 24 weeks, the reported data shows approximately 22.2% of participants improved by at least one category, 70.1% stayed the same, and 6.8% worsened. Some percentage breakdowns within those categories were reported as zero or not separately detailed in the submitted 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.

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

NCT00380068
Completed Phase 3 🇦🇺 Australian site

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 18 years of age or older
  • You have been diagnosed with pulmonary hypertension (high blood pressure in the lungs) caused by one of several specific conditions, including: idiopathic or familial pulmonary arterial hypertension (PAH), PAH linked to connective tissue disease, certain heart defects, HIV, certain drugs or toxins, thyroid disorders, or some blood/storage diseases; OR lung diseases such as COPD or interstitial lung disease; OR chronic blood clots in the lungs; OR sarcoidosis
  • You have been on a stable dose of certain approved pulmonary hypertension or related medications (such as a prostanoid, PDE-5 inhibitor, calcium channel blocker, or statin) for at least four weeks
  • You have had a right heart catheterization (a specific heart test) before the screening visit that meets the study's required results (confirm with trial site)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test and agree to use two reliable forms of contraception during the study and for at least four weeks after your final visit
  • If you are a man, you must be informed about and show you understand the potential risks of this medication to fertility (confirm with trial site)

Who may not be able to join:

  • You have previously taken part in a clinical study involving the drug ambrisentan
  • You have taken bosentan or sitaxsentan (similar medications) within the four weeks before your screening visit
  • Your liver enzyme levels (AST or ALT) are more than three times higher than the normal range at your screening visit
  • Your lung function or heart pressure test results do not meet the specific measurements required by the study (confirm with trial site)
  • You have a medical reason why you cannot take a type of medication called an endothelin receptor antagonist (confirm with trial site)
  • You have had a cancer diagnosis in the past five years, other than certain minor skin cancers or early-stage cervical cancer
  • You are currently pregnant or breastfeeding

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Lewis J Rubin, MD, University of California, San Diego

Australian sites

St. Vincent's Hospital, Darlinghurst, New South Wales
Royal Perth Hospital, Perth,

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

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
1 August 2006
Est. completion
1 July 2008

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov