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CXA-10 in Pulmonary Arterial Hypertension
NCT04125745Phase 2
Key facts
- Status
- Terminated
- Start
- Oct 2019
- Primary completion
- Dec 2020
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- 10-nitro-oleic acid
- Conditions
- pulmonary arterial hypertension (PAH)
01
Overview
Phase 2, open-label, single-arm trial of 10-nitro-oleic acid in pulmonary arterial hypertension (PAH). Primary endpoint: Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0 at 12 weeks. Started Oct 2019; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
CXA-10
Oral CXA-10 300 mg once daily for 12 weeks
03
Who it enrols
Adult patients with WHO Functional Class II or III PAH, on stable background therapy, with specific hemodynamic criteria (mPAP >= 25 mmHg, PVR >= 3 WU, PAWP <= 15 mmHg) and 6MWD between 100-600m.
04
Endpoints
Primary
Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Secondary
Change From Baseline in Pulmonary Vascular Resistance
Change From Baseline in Mean Pulmonary Artery Pressure
Change From Baseline in RV Function as Measured by Tricuspid Annular Plane Systolic Excursion
Changes From Baseline in Functional Exercise Capacity by Assessing 6 Minute Walk Distance Test
Change From Baseline in Levels of Serum N-terminal Pro-brain Natriuretic Peptide
Change From Baseline in Functional Status of Patients as Assessed by New York Heart Association Functional Class
Change From Baseline in Daily Physical Activity
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