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

Phase 3Active Not RecruitingNCT06683040

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation260 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

260

Conditions

Pulmonary Arterial Hypertension

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

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