Apabetalone for Pulmonary Arterial Hypertension: a Pilot Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pulmonary Arterial Hypertension
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Pilot study to assess the feasibility of a Phase 2 clinical trial assessing apabetalone in 10 PAH patientsMasking: None (Open Label)Primary Purpose: Screening
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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 fol...
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.
Tracking Information
- NCT #
- NCT03655704
- Collaborators
- Resverlogix Corp
- Investigators
- Principal Investigator: Steeve Provencher, MD, MSc IUCPQ-UL Principal Investigator: Sébastien Bonnet, PhD, FAHA IUCPQ-UL Study Director: Pascale Blais-Lecours, PhD IUCPQ-UL
Get Well Soon