Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02036970 |
Recruitment Status :
Completed
First Posted : January 15, 2014
Results First Posted : July 23, 2021
Last Update Posted : December 7, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | January 13, 2014 | ||
First Posted Date ICMJE | January 15, 2014 | ||
Results First Submitted Date ICMJE | December 31, 2020 | ||
Results First Posted Date ICMJE | July 23, 2021 | ||
Last Update Posted Date | December 7, 2021 | ||
Study Start Date ICMJE | May 2014 | ||
Actual Primary Completion Date | January 19, 2018 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo [ Time Frame: Baseline through Week 16 ] Overall treatment effect in exercise capacity, as measured by the total distance walked in 6 minutes (6MWD) mean change from baseline though Week 16. A lower 6MWD reflects greater severity thus, a positive change from baseline suggests an improvement.
|
||
Original Primary Outcome Measures ICMJE |
Change from baseline in 6-Minute Walk Distance (6MWD) [ Time Frame: 16 weeks ] | ||
Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT | ||
Official Title ICMJE | A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension | ||
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 Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
||
Condition ICMJE |
|
||
Intervention ICMJE |
|
||
Study Arms ICMJE |
|
||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
166 | ||
Original Estimated Enrollment ICMJE |
112 | ||
Actual Study Completion Date ICMJE | May 16, 2018 | ||
Actual Primary Completion Date | January 19, 2018 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||
Sex/Gender ICMJE |
|
||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Germany, United States | ||
Removed Location Countries | Spain, United Kingdom | ||
Administrative Information | |||
NCT Number ICMJE | NCT02036970 | ||
Other Study ID Numbers ICMJE | RTA 402-C-1302 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
|
||
Current Responsible Party | Reata Pharmaceuticals, Inc. | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Reata Pharmaceuticals, Inc. | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Reata Pharmaceuticals, Inc. | ||
Verification Date | November 2021 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |