Viewing Study NCT03655704



Ignite Creation Date: 2024-05-06 @ 12:01 PM
Last Modification Date: 2024-10-26 @ 12:53 PM
Study NCT ID: NCT03655704
Status: COMPLETED
Last Update Posted: 2022-04-25
First Post: 2018-08-28

Brief Title: Apabetalone for Pulmonary Arterial Hypertension a Pilot Study
Sponsor: Steeve Provencher
Organization: Laval University

Study Overview

Official Title: Apabetalone for Pulmonary Arterial Hypertension a Pilot Study
Status: COMPLETED
Status Verified Date: 2022-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: APPRoAcH-p
Brief Summary: The main OBJECTIVE of this proposal is to extend the investigators preclinical findings on the role of epigenetics and DNA damage and Bromodomain-Containing Protein 4 BRD4 inhibition as a therapy for a devastating disease pulmonary arterial hypertension PAH

There is strong evidence that BRD4 plays a key role in the pathological phenotype in PAH accounting for disease progression and that BRD4 inhibition can reverse PAH in several animal models Intriguingly coronary artery disease CAD and metabolic syndrome are more prevalent in PAH compared with the global population suggesting a link between these diseases Interestingly BRD4 is also a trigger for calcification and remodeling processes and regulates transcription of lipoprotein and inflammatory factors all of which are important in PAH and CAD Apabetalone an orally available BRD4 inhibitor is now in a clinical development stage with a good safety profile

At this stage the investigators propose a pilot study to assess the feasibility of a Phase 2 clinical trial assessing apabetalone in the PAH population The overall HYPOTHESIS is that BRD4 inhibition with apabetalone is a safe and effective therapy for PAH
Detailed Description: In line with most pilot and safety studies this is a two-centre Quebec and Calgary open-label trial A 4-week pre-treatment phase will allow ensuring that patients are on stable doses of medication Patients will be given doses of apabetalone 100mg BID for 16 weeks Patients will be regularly followed At baseline and week 16 a cardiac catheterization and MRI will assess changes in pulmonary hemodynamics and RV function

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None