Clinical Research Studies

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