NCT06683040

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

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Oxacom® in Different Dosages in Patients With Pulmonary Arterial Hypertension

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Oxacom	Lyophilisate for solution for intravenous administration, 6.3 mg
DRUG	Placebo	0.9% sodium chloride

Timeline

• Start date: 2024-06-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-11-12
• Last updated: 2026-04-08

Locations

1 site across 1 country: Russia