APD811-301 Phase 3 studies evaluating the efficacy and safety of ralinepag in patients with WHO Group 1 pulmonary arterial hypertension (PAH)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Pulmonary Arterial Hypertension
  • Age: Between 18 Year(s) - 75 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants will provide written informed consent
    2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
    3. Diagnosis of symptomatic pulmonary arterial hypertension (PAH)
    4. Has had a right heart catheterization (RHC) performed at or within 365 days of Screening
    5. If the subject is taking the following concomitant medications that may affect PAH, the subject must be on a stable dose for at least 30 days prior to the start of Screening and the dosage maintained throughout the study
      • Calcium channel blockers, digoxin, or L-arginine supplementation;
      • If the subject is taking anticoagulants, anticoagulation status must be maintained/stable in the therapeutic range for at least 30 days prior to the start of Screening
    6. Both male and female subjects agree to use a medically acceptable method of contraception throughout the entire study period from informed consent through to the Follow-up Visit, if the possibility of conception exists

You may not be eligible for this study if the following are true:

    1. Body weight <40 kg
    2. Body mass index (BMI) =40 kg/m2
    3. PAH diagnosis =5 years at Screening
    4. Group 2 to 5 pulmonary hypertension
    5. Presence of 3 or more of the following risk factors for heart failure with preserved ejection fraction at Screening
      • BMI >30 kg/m2
      • Diabetes mellitus of any type
      • Systemic hypertension
      • Significant coronary artery disease
    6. Echocardiogram (ECHO) within 365 days prior to Screening demonstrating significant left-sided heart disease
    7. Has a cardiac index (CI) of >3.2 L/min/m2
    8. Acutely decompensated heart failure within 30 days prior to Screening
    9. Evidence of protocol-defined significant cardiac disease history
    10. Has evidence of more than mild parenchymal lung disease on pulmonary function tests
    11. Has evidence of thromboembolic disease
    12. Uncontrolled systemic hypertension
    13. Hypotension (SBP <90 mmHg) at Screening
    14. History of orthostatic hypotension or orthostatic hypotension at Screening
    15. History of atrial septostomy within 180 days prior
    16. Diagnosis of Down syndrome
    17. Chronic liver disease, portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension
    18. Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
    19. Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =3 times the upper limit of normal (ULN) or total bilirubin =2xULN
    20. Chronic renal insufficiency
    21. Hemoglobin concentration <9 g/dL
    22. Required use of intravenous (i.v.) inotropes
    23. Malignancy within 5 years of Screening
    24. Recent history of alcohol or drug abuse
    25. Initiation of a cardio-pulmonary rehabilitation program
    26. Any reason that, in the opinion of the investigator or medical monitor, precludes the subject from participating in the study
    27. Life expectancy <12 months

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.