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NCT Number: NCT06683040

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

NMCRCardiologyRu

Moscow, 121552, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of PAH II or III functional class according to WHO classification
  • Symptomatic PAH group 1 according to clinical classification
  • Patients who have not previously received any PAH-specific therapy OR patients who have received endothelin receptor antagonists and/or iloprost/selexipag at stable doses for at least 3 months prior to the initial right heart catheterization.
  • Ability to perform reproducible 6-min walking test at the screening with a distance from 150 to 450 m.

Exclusion criteria

  • as per the study protocol

Treatment and study plan

Oxacom

Drug

Lyophilisate for solution for intravenous administration, 6.3 mg

Placebo

Drug

0.9% sodium chloride

Primary outcomes

  1. Pulmonary vascular resistance (PVR) will be measured to assess and evaluate the efficacy of study drug in comparison with placebo in patients with pulmonary arterial hypertension (PAH).

    Time frame: 6 hours after the start of the IP administration

    To evaluate the efficacy of single doses of the investigational product compared with placebo in patients with pulmonary arterial hypertension (PAH), we will measure pulmonary vascular resistance (PVR)

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 12, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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