Ignite Creation Date:
2024-05-06 @ 2:25 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02036970
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2014-01-13
Brief Title:
Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension PH - LARIAT
Sponsor:
Reata a wholly owned subsidiary of Biogen
Organization:
Biogen
Study Overview
Official Title:
A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension
Status:
COMPLETED
Status Verified Date:
2024-02
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:
None
Brief Summary:
This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with pulmonary hypertension to determine the recommended dose range evaluate the change from baseline in 6-minute walk distance 6MWD and determine the effect of Bardoxolone methyl in pulmonary hypertension associated with connective tissue disease interstitial lung disease and idiopathic etiologies including subsets of patients with WHO Group III or WHO Group V PH following 16 weeks of study participation
Detailed Description:
The molecular and pharmacological effects of bardoxolone methyl are broad through its induction of Nrf2 and suppression of NF-κB Bardoxolone methyl may therefore address multiple facets of the pathophysiology of PH because it suppresses activation of proinflammatory mediators enhances endothelial NO bioavailability improves metabolic dysfunction suppresses vascular proliferation and prevents maladaptive remodeling Furthermore while existing therapies primarily target only smooth muscle cells bardoxolone methyl targets multiple cell types relevant to PH including endothelial cells smooth muscle cells and macrophages
This is a two-part study
Part 1 Part 1 of the study will include a dose-ranging phase and a dose-titration phase
Part 2 extension period All patients from Part 1 who complete the 16-week treatment period as planned will be eligible to continue directly into the extension period to evaluate the intermediate and long-term safety and efficacy of bardoxolone methyl
Study Sponsor originally Reata Pharmaceuticals Inc is now Reata Pharmaceuticals Inc a wholly owned subsidiary of Biogen
This is a two-part study
Part 1 Part 1 of the study will include a dose-ranging phase and a dose-titration phase
Part 2 extension period All patients from Part 1 who complete the 16-week treatment period as planned will be eligible to continue directly into the extension period to evaluate the intermediate and long-term safety and efficacy of bardoxolone methyl
Study Sponsor originally Reata Pharmaceuticals Inc is now Reata Pharmaceuticals Inc a wholly owned subsidiary of Biogen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None