Phase 4 Pulmonary Hypertension Trial, Recruiting NCT06317805 Sponsor: AOP Orphan Pharmaceuticals AG Condition: Pulmonary Hypertension
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Phase 4 Pulmonary Hypertension Trial, Recruiting

NCT06317805
Recruiting Phase 4

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 aged 18 to 70 years old
  • You have been diagnosed with pulmonary arterial hypertension (PAH) — a type of high blood pressure affecting the lungs — and have not yet received any treatment for it
  • Your PAH falls into one of these specific types: the cause is unknown (idiopathic), it runs in your family (hereditary), it was caused by a drug or toxin, it is linked to a connective tissue disease (such as lupus or rheumatoid arthritis), or it is related to a congenital heart defect that has been surgically corrected
  • Based on a specialist risk assessment tool, your condition is rated as intermediate-high risk, or intermediate-low risk with certain severe measurements of heart function (confirm with trial site)
  • A specific heart and lung pressure test (called a right heart catheterisation) has shown particular pressure and resistance readings in your lungs that meet the trial's requirements (confirm with trial site)
  • You have agreed to sign a consent form before any trial procedures begin
  • If you are a woman who could become pregnant, you are not currently pregnant or breastfeeding, you agree to use reliable contraception throughout the trial, and you agree to have regular pregnancy tests

Who may not be able to join:

  • Your PAH is linked to a parasitic infection (schistosomiasis), HIV, high blood pressure in the liver (portal hypertension), a severe form of systemic sclerosis (diffuse type), or a heart defect that has not been surgically corrected
  • You have taken any PAH-specific medication in the past 3 months
  • Your PAH responded well to a type of blood pressure medication called calcium channel blockers during a specific test
  • Your high lung blood pressure is caused by a problem on the left side of the heart
  • You have a rare lung condition called pulmonary veno-occlusive disease (PVOD), or it is suspected
  • Your high lung blood pressure is caused by a lung disease
  • You have a significant breathing or lung function problem shown by specific lung tests and scan results (confirm with trial site)
  • You need to use oxygen at home or on an ongoing basis
  • A heart tracing test (ECG) showed an abnormal heart rhythm reading above a certain level (confirm with trial site)
  • Your body mass index (BMI) is above 35
  • You are over 70 years old
  • You have a history of certain serious heart conditions, including heart muscle disease, a procedure to create a hole between the upper chambers of the heart (atrial septostomy), significant coronary artery disease events in the past 6 months, severely uncontrolled high blood pressure, a recent heart attack (within 30 days), serious heart valve problems, chronically low blood pressure, unstable chest pain, or a permanent irregular heart rhythm (atrial fibrillation) or need for a pacemaker
  • You have severe anaemia (low red blood cell levels below a certain threshold)
  • You have had a stroke within the past 3 months
  • You have severe liver disease meeting specific medical criteria (confirm with trial site)
  • You have significant kidney disease where your kidneys are filtering at a reduced rate below a certain level (confirm with trial site)
  • You have untreated sleep apnoea
  • You have another serious ongoing condition affecting the heart, liver, kidneys, blood, digestive system, immune system, hormones (such as uncontrolled diabetes), nervous system, or you have active bleeding or recent serious injury — if the trial doctor believes this could affect your safety or how long you are likely to live
  • You have had major surgery in the past 12 months
  • You have a known history of alcohol misuse
  • You have taken certain medications that affect how the body processes drugs (specific enzyme inducers or inhibitors) within the past 28 days (confirm with trial site)
  • You have recently taken part in another clinical drug trial or are currently doing so
  • You have a known allergy or sensitivity to any of the trial medications or their ingredients
  • You are pregnant, breastfeeding, or planning to become pregnant during the trial
  • The trial doctor believes any other condition or factor may put you at risk or affect your ability to follow the trial's requirements

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 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: +43676 3464650

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
AOP Orphan Pharmaceuticals AG
Registry
ClinicalTrials.gov
Start date
6 December 2023
Est. completion
1 June 2027

Where this trial is recruiting

🇦🇹 Austria 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇹 Italy 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇪🇸 Spain

Primary endpoints

Patients achieving (non-)response status to the assigned treatment in terms of achievement of low-risk status

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