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

NCT06683040 | Active Not Recruiting Phase 2

• 2 other identifiers: OXA-PAH-1ОКСА-ЛАГ-1
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oxaсom; Pulmonary Arterial Hypertension; New Russian drug

Outcome Measures

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).

  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

Study Arms (4)

0.030 mg\kg

EXPERIMENTAL

Drug: Oxacom

0.100 mg\kg

EXPERIMENTAL

Drug: Oxacom

0.170 mg\kg

EXPERIMENTAL

Drug: Oxacom

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oxacom DRUG

Lyophilisate for solution for intravenous administration, 6.3 mg

0.030 mg\kg; 0.100 mg\kg; 0.170 mg\kg

Placebo DRUG

0.9% sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• as per the study protocol

Sponsors & Collaborators

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

Study Sites (1)

NMCRCardiologyRu

Moscow, 121552, Russia

Location

Related Links

• Russian registry of clinical trials record

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tamila V Martynyuk, MD

  E.I.Chazov Cardiology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)