Ignite Creation Date:
2024-05-06 @ 8:03 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02657356
Status:
TERMINATED
Last Update Posted:
2024-02-06
First Post:
2016-01-13
Brief Title:
Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST
Sponsor:
Reata a wholly owned subsidiary of Biogen
Organization:
Biogen
Study Overview
Official Title:
A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension
Status:
TERMINATED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Exposure of these high-risk patients to clinic or in-person visits during the pandemic presented an unacceptable risk to their health
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 connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance 6MWD following 24 weeks of study participation
Detailed Description:
This double-blind randomized placebo-controlled trial will study the safety tolerability and efficacy of bardoxolone methyl in qualified patients with World Health Organization Group I Connective Tissue Disease Pulmonary Arterial Hypertension WHO Group I CTD-PAH
Qualified patients will be randomized 11 to either bardoxolone methyl or placebo to be administered once daily for 24 weeks Patients randomized to placebo will remain on placebo throughout the study Patients randomized to bardoxolone methyl will start at 5 mg and will dose-escalate to 10 mg at Week 4 unless contraindicated clinically Dose de-escalation is permitted during the study if indicated clinically
All patients in the study will follow the same visit and assessment schedule Following randomization patients will be scheduled to be assessed in person during treatment at Weeks 1 2 4 6 8 16 and 24 and by telephone contact on Days 3 10 21 31 38 84 and 140 Patients will also be scheduled to be assessed at an in person follow up visit at Week 28 four weeks after the end of treatment
Study Sponsor originally Reata Pharmaceuticals Inc is now Reata Pharmaceuticals Inc a wholly owned subsidiary of Biogen
Qualified patients will be randomized 11 to either bardoxolone methyl or placebo to be administered once daily for 24 weeks Patients randomized to placebo will remain on placebo throughout the study Patients randomized to bardoxolone methyl will start at 5 mg and will dose-escalate to 10 mg at Week 4 unless contraindicated clinically Dose de-escalation is permitted during the study if indicated clinically
All patients in the study will follow the same visit and assessment schedule Following randomization patients will be scheduled to be assessed in person during treatment at Weeks 1 2 4 6 8 16 and 24 and by telephone contact on Days 3 10 21 31 38 84 and 140 Patients will also be scheduled to be assessed at an in person follow up visit at Week 28 four weeks after the end of treatment
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