RecruitingPhase 2Phase 3NCT06683040

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

Sponsor

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Enrollment

260 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Pulmonary Arterial Hypertension

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called Oxacom can improve exercise ability and symptoms in people with pulmonary arterial hypertension (PAH) — a serious condition where the blood pressure in the lungs is dangerously high, making it difficult to breathe and exercise. **You may be eligible if...** - You have a confirmed diagnosis of PAH with WHO functional class II or III symptoms (moderate to significant limitations on physical activity) - You either have not received any PAH-specific treatment before, or you have been on a stable dose of certain PAH drugs (endothelin receptor antagonists or prostacyclin agents) for at least 3 months - You are able to walk between 150 and 450 meters in a 6-minute walking test **You may NOT be eligible if...** - You have PAH caused by certain underlying conditions excluded by the protocol - Your 6-minute walk distance falls outside the required range - You have other serious conditions that may affect the study results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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