Pulmonary Arterial HypertensionPhase 2/3NCT06683040
Evaluation of the Efficacy and Safety of Oxacom® in Patients With Pulmonary Arterial Hypertension
A Phase 2/3 study testing Oxacom in people with Pulmonary Arterial Hypertension, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Oxacom
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jun 2024to 31 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- as per the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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
- Being tested
- Oxacom, Placebo
- Keywords
- Oxaсom, Pulmonary Arterial Hypertension, New Russian drug
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxacomDrug
Lyophilisate for solution for intravenous administration, 6.3 mg
PlaceboDrug
0.9% sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| 0.030 mg\kg | Experimental | Not described Receives: Drug: Oxacom |
| 0.100 mg\kg | Experimental | Not described Receives: Drug: Oxacom |
| 0.170 mg\kg | Experimental | Not described Receives: Drug: Oxacom |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 hours after the start of the IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tamila V Martynyuk, MD, Principal investigator, E.I.Chazov Cardiology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683040
- Sponsor's protocol ID
- OXA-PAH-1
- Other IDs
- ОКСА-ЛАГ-1
- Status last verified
- Apr 2026
- First submitted
- 7 Nov 2024
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06683040
- Acronym / sponsor ID
- OXA-PAH-1
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Oxaсom, Pulmonary Arterial Hypertension, New Russian drug
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (actual)
- Lead sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian FederationOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- as per the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxacomLyophilisate for solution for intravenous administration, 6.3 mg | Drug | 0.030 mg\kg, 0.100 mg\kg, 0.170 mg\kg |
| Placebo0.9% sodium chloride | Drug | Placebo |
Primary outcome
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).
Time frame: 6 hours after the start of the IP administration
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamila V Martynyuk, MD principal investigator
E.I.Chazov Cardiology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxacom in people with Pulmonary Arterial Hypertension, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 6 hours after the start of the IP administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.