Apabetalone for Pulmonary Arterial Hypertension
(APPROACH-2 Trial)

Recruiting in Palo Alto (17 mi)

Overseen bySteeve 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.

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.

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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.

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Treatment Details

Interventions

Apabetalone (Bromodomain and Extraterminal Domain (BET) Inhibitor)

Trial OverviewThe 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.