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Active Clinical Trials

REPLACE

Active NCT:
02891850
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Bayer
Contact: 

For more information, please contact Joan Rossi at 412-359-3293 or Joan.Rossi@ahn.org

A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal

Purpose: 

To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
 
Inclusion Criteria:
 
  • Male and female patients aged 18 to 75 years.
  • Patients with symptomatic PAH with a pulmonary vascular resistance (PVR) > 400 dyn*sec*cm-5, mean pulmonary artery pressure ≥ 25 mmHg, and pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg as assessed by the most recent right heart catheterization (RHC) from medical history prior to screening to confirm the diagnosis. Alternatively, PCWP can be replaced by left ventricular end-diastolic pressure (≤ 15 mmHg). PAH of the following types:
    • Idiopathic
    • Hereditary
    • Drug and toxin induced PAH
    • Associated with PAH due to:
      • Connective tissue disease (CTD)
      • Congenital heart disease, but only if the patient underwent surgical repair more than one year before enrolment
      • Portal hypertension with liver cirrhosis (Note: patients with clinical relevant hepatic dysfunction are excluded; see exclusions related to disorders in organ function)
  • Patients who are on stable doses of a PDE-5i and ERA combination therapy or on stable PDE-5i monotherapy 6 weeks prior to and at randomization but not at treatment goal (tadalafil 20 to 40 mg once daily or sildenafil at least 60 mg daily dose).
  • WHO FC III at screening and at randomization.
  • 6MWD test between 165 m and 440 m at screening and at randomization.
  • Stable dose of diuretics, if used, for at least 30 days prior to and at randomization.
  • Patients who are able to understand and follow instructions and who are able to participate in the study for the entire study.
  • Women of childbearing potential must agree to use adequate contraception when sexually active. Adequate contraception is defined as any combination of at least 2 effective methods of birth control, of which at least 1 is a physical barrier (e.g. condom with hormonal contraception like implants or combined oral contraceptives, condom with intrauterine devices). This applies beginning with signing of the informed consent form until 30 (+5) days after the last administration of study drug.
  • Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures.

​​

Exclusion Criteria:

  • Participation in another interventional clinical study within 30 days prior to screening.
  • All types of PH (including PH-IIP) except subtypes of Dana Point Group I specified in the inclusion criteria.
  • Previous treatment with riociguat.
  • Pregnant women (i.e., positive serum ß-human-chorionic-gonadotropin test or other signs of pregnancy), or breast feeding women, or women with childbearing potential not using a combination of 2 effective contraception methods (as laid out in inclusion criterion) throughout the study.
  • Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study, in the opinion of the investigator.
  • Relevant obstructive and restrictive or other lung diseases.
  • Patients with underlying medical disorders with an anticipated life expectancy below 2 years (e.g., active cancer disease with localized and/or metastasized tumor mass).
  • Cardiovascular exclusion criteria like left ventricular disease, coronary heart disease or stroke within previous 3 months.
  • Patients with hypersensitivity to the investigational drug or any of the excipients.
  • Patients unable to perform a valid 6MWD test (e.g., orthopedic disease, peripheral artery occlusive disease, which affects the patient's ability to walk). Note: Patients, who require walking aids, may be included if in the opinion of the investigator the walking distance is not impaired. Patients with a variance of more than 15% between the screening and the randomization (i.e., baseline) 6MWD test.