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

NCT06683040 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-04-08

No results posted yet for this study

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

Interventions

DRUG

Oxacom

Lyophilisate for solution for intravenous administration, 6.3 mg

DRUG

Placebo

0.9% sodium chloride

Sponsors & Collaborators

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

    lead OTHER_GOV

Principal Investigators

  • Tamila V Martynyuk, MD · E.I.Chazov Cardiology Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06683040 on ClinicalTrials.gov