72 Participants Needed

Apabetalone for Pulmonary Arterial Hypertension

(APPROACH-2 Trial)

SP
PB
Overseen ByPascale Blais-Lecours, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Must be taking: Vasoactive therapy
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests a new pill that may help reduce the severity of Pulmonary Arterial Hypertension (PAH) and improve heart and lung function in adults who are already on stable treatment.

Research Team

Principal investigators - PHRG

Steeve Provencher, MD

Principal Investigator

IUCPQ-UL

PB

Pascale Blais-Lecours, PhD

Principal Investigator

IUCPQ-UL

Eligibility Criteria

Adults aged 18-75 with Pulmonary Arterial Hypertension (PAH) who are stable on current PAH medication for at least 3 months can join. They must be able to walk at least 150 meters and have a life expectancy of more than 28 weeks. Participants need normal organ function, not be pregnant or breastfeeding, and agree to use contraception if necessary.

Inclusion Criteria

Your body mass index (BMI) is between 18 and 40.
My pulmonary arterial hypertension is due to genetics, drugs, toxins, or related to a heart defect that was corrected over a year ago.
I am postmenopausal, sterilized, using contraception, or not engaging in activities that could lead to pregnancy.
See 10 more

Exclusion Criteria

Your doctor thinks you may not live for more than 1 year because of other health issues.
My pulmonary hypertension is not caused by left heart diseases, lung diseases, chronic blood clots, or multiple factors.
I have severe lung disease that affects my breathing.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Pre-treatment

A 4-week pre-treatment phase to ensure patients are on stable doses of PAH medication

4 weeks
Regular monitoring visits

Treatment

Participants receive apabetalone 100mg BID or placebo for 24 weeks

24 weeks
Baseline, week 8, and week 24 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
End-of-study visit at week 28

Treatment Details

Interventions

  • Apabetalone
Trial Overview The trial is testing the effectiveness of Apabetalone as an additional treatment for PAH over a period of 24 weeks. It will compare changes in pulmonary vascular resistance (PVR) between those taking Apabetalone and those given a placebo while continuing their usual PAH therapy.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: ApabetaloneActive Control1 Intervention
100mg BID, 24-week (168±3 days) Treatment Period.
Group II: PlaceboPlacebo Group1 Intervention
24-week (168±3 days) period.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Lead Sponsor

Trials
26
Recruited
6,300+

Laval University

Lead Sponsor

Trials
439
Recruited
178,000+

Resverlogix Corp

Industry Sponsor

Trials
13
Recruited
3,700+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security