Reata - 402-C-1302 - Pulmonary Hypertension
Research type
Research Study
Full title
A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Pulmonary Hypertension
IRAS ID
225593
Contact name
John Coghlan
Contact email
Sponsor organisation
Reata Pharmaceuticals, Inc.
Eudract number
2016-004793-17
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
Initial results show that bardoxolone methyl, at dosages of 2.5 mg to 20 mg, increases the capability of performing tasks and activities in patients with pulmonary arterial hypertension (PAH) patients on one or more background PAH therapies. \n\nBardoxolone methyl has a dual mechanism of action: \n• It is a potent activator of a protein (known as “Nrf2“) that helps reduce damage caused by inflammation \n• It is an inhibitor of a protein (known as “NF-kB“) that increases inflammation\n\nThis trial is a dose-ranging study of the efficacy and safety of bardoxolone methyl in patients with Pulmonary Hypertension. This study consists of two parts: \n• a 16-week double-blind, randomized, placebo-controlled treatment period (“Part 1”), \n• followed by an open-label extension period (“Part 2”). \n\nAll patients who complete treatment in Part 1 may continue to Part 2. Within Part 1, the study globally consists of a dose-ranging phase and a dose-titration phase. Qualifying patients with PH in both the dose-ranging and dose titration phases will be followed for safety, tolerability, and efficacy, and all patients enrolled in the study will follow a similar schedule of assessments.\n\nApproximately 198 people aged 18-75 years old will be treated in this trial. This trial is being conducted in approximately 80 locations globally with 2 locations in the UK.\n
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/0944
Date of REC Opinion
14 Jul 2017
REC opinion
Further Information Favourable Opinion