Trial · NCT02036970
Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT
NCT02036970, Phase 2, Completed, Biogen; results first posted 2021-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT. Trials, record NCT02036970. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02036970
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT
- NCT number
- NCT02036970
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 166 participants, actual
- Lead sponsor
- Biogen
- Conditions
Pulmonary Arterial Hypertension, Pulmonary Hypertension, Interstitial Lung Disease, Idiopathic Interstitial Pneumonia, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Respiratory Bronchiolitis Associated Interstitial Lung Disease, Desquamative Interstitial Pneumonia, Cryptogenic Organizing Pneumonia, Acute Interstitial Pneumonitis, Idiopathic Lymphoid Interstitial Pneumonia, Idiopathic Pleuroparenchymal Fibroelastosis
- Interventions
- Bardoxolone methyl, Placebo
- First posted
- 2014-01-15
- Last updated
- 2025-06-10
- Results first posted
- 2021-07-23
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo | Baseline through Week 16 | mITT population included all randomized patients receiving at least 28 doses of study treatment, did not undergo heart or lung transplantation during the treatment period, and performed at least one-post baseline 6MWD assessment. Only Part 1 patients are included since the primary outcome is the change from baseline in 6MWD through Week 16. Primary outcome assessed for subgroups of participants with PAH from Cohorts 1, 2 and 3 of the study and participants with PH, Cohort 4 of the study. | meters | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo | Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label | Change from Baseline though Week 16 for participants with PAH | 32.5 | Standard Deviation 29.14 | meters |
| Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo | Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label | Change from Baseline though Week 16 for participants with PAH | 24 | Standard Deviation 30.08 | meters |
| Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo | Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label | Change from Baseline though Week 16 for participants with PAH | 3.4 | Standard Deviation 31.28 | meters |
| Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo | Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label | Change from Baseline though Week 16 for participants with PAH | -3.2 | Standard Deviation 39.53 | meters |
| Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo | Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg | Change from Baseline though Week 16 for participants with PAH | 20.3 | Standard Deviation 13.08 | meters |
| Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo | Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg | Change from Baseline though Week 16 for participants with PAH | 24.6 | Standard Deviation 59.4 | meters |
| Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo | Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg | Change from Baseline though Week 16 for participants with PAH | 23.8 | Standard Deviation 34.54 | meters |
| Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo | Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg | Change from Baseline though Week 16 for participants with PAH | -21.8 | Standard Deviation 4.17 | meters |
| Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo | Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg | Change from Baseline though Week 16 for participants with PAH | 13.9 | Standard Deviation 41.15 | meters |
| Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo | Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg | Change from Baseline though Week 16 for participants with PAH | 19.4 | Standard Deviation 21.06 | meters |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow220
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1: Day 1 Through Week 16 | STARTED | Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label | 6 | |
| Part 1: Day 1 Through Week 16 | STARTED | Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label | 12 | |
| Part 1: Day 1 Through Week 16 | STARTED | Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label | 11 | |
| Part 1: Day 1 Through Week 16 | STARTED | Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label | 12 | |
| Part 1: Day 1 Through Week 16 | STARTED | Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg | 2 | |
| Part 1: Day 1 Through Week 16 | STARTED | Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg | 4 | |
| Part 1: Day 1 Through Week 16 | STARTED | Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg | 3 | |
| Part 1: Day 1 Through Week 16 | STARTED | Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg | 4 | |
| Part 1: Day 1 Through Week 16 | STARTED | Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg | 74 | |
| Part 1: Day 1 Through Week 16 | STARTED | Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg | 38 |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 participant flowAdverse events7,400
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label | 1 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label | 0 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label | 0 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg | 1 | 74 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg | 0 | 38 |
1 to 10 of 7,400Source ClinicalTrials.gov
See all 7,400 adverse eventsAdverse event totals60
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 2.5 mg/Part 2: Open-Label | 0 | 6 |
| Total, all-cause mortality | Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 5 mg/Part 2: Open-Label | 0 | 12 |
| Total, all-cause mortality | Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 10 mg/Part 2: Open-Label | 0 | 11 |
| Total, all-cause mortality | Part 1 Period of Part 1: Dose-Ranging Bardoxolone Methyl 20 mg/Part 2: Open-Label | 0 | 12 |
| Total, all-cause mortality | Part 1 Period of Part 1: Dose-Ranging Placebo 2.5 mg/Part 2: Bardoxolone Methyl 2.5 mg | 0 | 2 |
| Total, all-cause mortality | Part 1 Period of Part 1: Dose-Ranging Placebo 5 mg/Part 2: Bardoxolone Methyl 5 mg | 0 | 4 |
| Total, all-cause mortality | Part 1 Period of Part 1: Dose-Ranging Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg | 0 | 3 |
| Total, all-cause mortality | Part 1 Period of Part 1: Dose-Ranging Placebo 20 mg/Part 2: Bardoxolone Methyl 20 mg | 0 | 4 |
| Total, all-cause mortality | Part 1 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg | 1 | 74 |
| Total, all-cause mortality | Part 1 Period of Part 1: Dose Titration: Placebo 10 mg/Part 2: Bardoxolone Methyl 10 mg | 0 | 38 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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