Apabetalone for Pulmonary Arterial Hypertension

(APPROACH-2 Trial)

Overseen By Pascale 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

Must not be taking: Strong CYP3A inhibitors

Disqualifiers: HIV, Portal hypertension, Lung diseases, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 37

Duration: 24 weeks

72 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Steeve Provencher, MD

Principal Investigator

IUCPQ-UL

Pascale Blais-Lecours, PhD

Principal Investigator

IUCPQ-UL

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Apabetalone Active Control 1 Intervention

100mg BID, 24-week (168±3 days) Treatment Period.

Group II: Placebo Placebo Group 1 Intervention

24-week (168±3 days) period.

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+