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Evaluation of the Efficacy and Safety of Oxacom® in Patients With Pulmonary Arterial Hypertension

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Oct 1, 2025 to Dec 31, 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A multicenter, randomized, double-blind, placebo-controlled, phase II-III clinical trial to evaluate the efficacy and safety of the study drug in adult patients with pulmonary arterial hypertension (PAH). The trial will evaluate the efficacy and safety of both single and multi-dose (seven-day) administrations of the study drug in three dosages: 0.03 mg/kg, 0.10 mg/kg, and 0.17 mg/kg. The trial is an observer-blinded trial, since the appearance of the study drug and Placebo differs from each other. Patients included in the trial, as well as trial coordinators, investigators, and study center staff will be blinded. The only unblinded staff in the study centers will be those who preparing IP/Placebo and administering IP/Placebo to the study patients. The trial will include 200 patients with PAH, who will be sequentially included in the trial in two stages.
Trial Details
NCT Number NCT06683040
Lead Sponsor National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Conditions
(from sponsor)		 Pulmonary Arterial Hypertension
Related terms Pulmonary Arterial Hypertension
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov