Evaluating a new drug for pulmonary arterial hypertension
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
PHASE2; PHASE3 · National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · NCT06683040
This study is testing a new drug called Oxacom® to see if it can help adults with pulmonary arterial hypertension feel better compared to a placebo.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation (other gov) |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06683040 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multicenter, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of Oxacom® in adult patients diagnosed with pulmonary arterial hypertension (PAH). The trial will involve 200 participants who will receive either the study drug or a placebo in varying dosages over a seven-day period. The study will be conducted in two stages, with a focus on patients who have not previously received PAH-specific therapy or have been on stable doses of certain treatments for at least three months. The trial will utilize a blinded approach to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a confirmed diagnosis of PAH functional class II or III who can perform a 6-minute walking test.
Not a fit: Patients with advanced PAH or those who have previously received PAH-specific therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from pulmonary arterial hypertension.
How similar studies have performed: Other studies have shown promise in evaluating new treatments for PAH, but the specific approach of this trial with Oxacom® is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Moscow
- NMCRCardiologyRu — Moscow, Russian Federation (RECRUITING)
Study contacts
- Principal investigator: Tamila V Martynyuk, MD — E.I.Chazov Cardiology Center
- Study coordinator: Vadim Yu Kuznetsov, PhD
- Email: vykuznetsov@cardio.ru
- Phone: +74954146249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Arterial Hypertension, Oxaсom, New Russian drug