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

April 7, 2026 updated by: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Moscow, Russia, 121552
        • NMCRCardiologyRu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
0.9% sodium chloride
Experimental: 0.030 mg\kg
Drug: Oxacom
Lyophilisate for solution for intravenous administration, 6.3 mg
Experimental: 0.100 mg\kg
Drug: Oxacom
Lyophilisate for solution for intravenous administration, 6.3 mg
Experimental: 0.170 mg\kg
Drug: Oxacom
Lyophilisate for solution for intravenous administration, 6.3 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 hours after the start of the IP administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Tamila V Martynyuk, MD, E.I.Chazov Cardiology Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

November 8, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXA-PAH-1
  • ОКСА-ЛАГ-1 (Other Identifier: Protocol ID in Cyrillic script)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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