Phase 3 Pulmonary Hypertension Trial, Recruiting NCT07218029 Sponsor: Merck Sharp & Dohme LLC Condition: Pulmonary Hypertension
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Phase 3 Pulmonary Hypertension Trial, Recruiting

NCT07218029
Recruiting 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:

  • People who have fully completed a previous clinical study of sotatercept for pulmonary arterial hypertension (a type of high blood pressure affecting the lungs), including all of that study's requirements, and who did not leave that study early
  • People who are willing and able to attend all required study visits and follow all study rules and requirements
  • People who are able to understand the study and have signed a formal consent form agreeing to take part

Who may not be able to join:

  • People who did not take part in a previous sotatercept study for pulmonary arterial hypertension
  • People who missed more than 4 doses in a row between the end of the previous study and the start of this one
  • People who experienced a serious side effect during a previous sotatercept study that doctors believe was possibly or probably caused by sotatercept, and that side effect is still ongoing
  • People who are currently pregnant or breastfeeding
  • People who are employed by, or have a close family member directly employed by, the organisation running or sponsoring this study
  • People who are currently enrolled in another clinical trial of an experimental treatment (other than a sotatercept study)
  • People who are unable to make decisions for themselves or manage their own affairs (confirm with trial site)

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 28 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: Medical Director, Merck Sharp & Dohme LLC

Phone: 1-888-577-8839

Australian sites

Royal Prince Alfred Hospital ( Site 1106), Camperdown, New South Wales
+61295158195
The Prince Charles Hospital ( Site 1104), Chermside, New South Wales
+61731395076
John Hunter Hospital ( Site 1101), New Lambton Heights, New South Wales
Royal Adelaide Hospital ( Site 1109), Adelaide, South Australia
+61870740000
Royal Hobart Hospital ( Site 1107), Hobart, Tasmania
+61361668620
Fiona Stanley Hospital ( Site 1103), Murdoch, Western Australia

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
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
12 May 2021
Est. completion
7 December 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇵🇹 Portugal 🇷🇸 Serbia 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Number of Participants Who Experience an Adverse Event (AE); Number of Participants Who Discontinue Study Treatment Due to an AE; Number of Participants with Detectable Anti-Drug Antibodies (ADAs); Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin; Laboratory parameters (Chemistry): Concentration of Creatinine, Total Bilirubin, and Alanine Aminotransferase (ALT); Change From Baseline in Body Weight; Change From Baseline in Blood Pressure; Change From Baseline in Electrocardiogram (ECG)

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: 28 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