NCT06683040Active, not recruitingPhase 2/3
Evaluation of the Efficacy and Safety of Oxacom® in Patients With 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
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 260 (actual)
- First submitted
- 7 Nov 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- NCT number
- NCT06683040
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 260
- From 1 Jun 2024 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- as per the study protocol
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NMCRCardiologyRu Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.