17 February 2023

Sponsored: Pulmonary Arterial Hypertension clinical trial

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A Phase 2/3 study of an inhaled sGC stimulator to evaluate the efficacy and safety of MK-5475 in adults with Pulmonary Arterial Hypertension (PAH).

Trial participants

Participants may qualify to be enrolled if:

  • Male or female, from 18 years to 75 years of age (inclusive) ​​​​​​​
  • Diagnosis of the following PAH sub-groups: Idiopathic PAH, Heritable PAH, Drug and toxin-induced PAH, PAH associated with connective tissue disease, HIV infection or simple repaired congenital systemic-to-pulmonary shunt with persistent PH ≥1 year after surgical repair
  • Diagnosis of PAH performed as standard of care, per scientific guidelines, and documented by RHC
  • Eligibility RHC, meeting all the following criteria: mPAP ≥25 mmHg, PVR of ≥3 Wood units, PCWP or LVEDP ≤15 mmHg
  • WHO-FC II to IV
  • Two 6MWD measurements between 150 and 500 meters (Screening & Randomization) 
  • Stable concomitant background PAH-specific therapy (no change in drug within 90 days and no change in dosage within 30 days prior to and over the duration of Screening)​​​​​​​​​​​​
  • Other criteria apply

The ongoing Phase 2 segment of the trial has 3 parts:

  • Screening period up to 4 weeks long
  • Trial Base Period for 12 weeks
  • Trial extension (Optional) for 24 months

Trial medication

MK-5475 is a dry powder for once daily oral inhalation using a dry powder inhaler.

Trial procedures

Include physical examination, laboratory tests, ECG, echocardiography, pulmonary function tests, right heart catheterization, 6-minute walk test, and QoL questionnaires.

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