Apabetalone for Pulmonary Arterial Hypertension

(APPROACH-2 Trial)

Overseen by Steeve Provencher, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

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

Prior Safety Data

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

Steeve Provencher, MD

Principal Investigator

IUCPQ-UL

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.

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.

Treatment Details

Interventions

• Apabetalone (Bromodomain and Extraterminal Domain (BET) Inhibitor)

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

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+

Dr. Pedro O de Campos-Lima

Laval University

Chief Medical Officer since 1998

MD from Federal University of Juiz de Fora, PhD in Tumor Biology from Karolinska Institute

Dr. Manuel Caruso

Laval University

Chief Executive Officer since 1998

PhD in Virology from Pierre and Marie Curie University

Resverlogix Corp

Industry Sponsor

Trials

13

Recruited

3,700+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa