Phase 2 Pulmonary Hypertension Trial, Recruiting NCT06649110 Sponsor: Novartis Pharmaceuticals Condition: Pulmonary Hypertension
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Phase 2 Pulmonary Hypertension Trial, Recruiting

NCT06649110
Recruiting Phase 2 🇦🇺 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:

Part A (Healthy Volunteer Phase):

  • People who are male, or female and not able to become pregnant, and are in general good health

Part B (Patient Phase):

  • People who have a confirmed diagnosis of pulmonary arterial hypertension (a type of high blood pressure affecting the lungs)
  • People whose lung blood vessel resistance has been measured at a specific level (≥400 dyn.sec.cm-5) before the study begins (confirm with trial site)
  • People who are already receiving stable, ongoing standard treatments for their condition
  • People who are able to walk between 150 and 450 metres in a 6-minute walk test

Who may not be able to join:

Part A (Healthy Volunteer Phase):

  • People who have significant heart rhythm problems or other heart abnormalities
  • People who have had surgery or have a medical condition that could affect how the body processes medication, or that could put them at risk during the study
  • For Japanese-specific groups: people who are not first to third generation Japanese, as defined in the study protocol (confirm with trial site)

Part B (Patient Phase):

  • People who have a surgical or medical condition that could put them at greater risk by participating in the study
  • Women who are able to become pregnant, unless highly effective contraception is being used
  • Males who are sexually active and unwilling to use a condom during and for 24 hours after stopping study treatment
  • People who have had an allergic reaction to any of the study treatments or their ingredients

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 27 July 2026
Phase 2: approximately ~30% 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: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Phone: 1-888-669-6682

Australian sites

Novartis Investigative Site, Camperdown, New South Wales
Novartis Investigative Site, Darlinghurst, New South Wales
Novartis Investigative Site, New Lambton Heights, New South Wales
Novartis Investigative Site, Adelaide, South 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 2
Registry
ClinicalTrials.gov
Start date
24 October 2024
Est. completion
29 November 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇹 Italy 🇱🇻 Latvia 🇲🇽 Mexico 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇸 Serbia 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Part A- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs); Part B-Treatment Period 1: Change in pulmonary vascular resistance (PVR); Part B-Treatment Period 2: Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)

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: 27 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