Trial · NCT03068130
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
NCT03068130, Phase 3, Terminated, Biogen; results first posted 2023-10-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER. Trials, record NCT03068130. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03068130
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
- NCT number
- NCT03068130
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 261 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Pulmonary Hypertension
- Interventions
- Bardoxolone methyl
- First posted
- 2017-03-01
- Last updated
- 2025-06-11
- Results first posted
- 2023-10-12
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study | From time of first dose until the final visit, up to 172 weeks | Severity was defined using the following definitions: Mild: Symptoms causing no or minimal interference with usual social and functional activities; Moderate: Symptoms causing greater than minimal interference with usual social and functional activities; Severe: Symptoms causing inability to perform usual social and functional activities. |
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 | Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study | From time of first dose until the final visit, up to 172 weeks | Safety population (all patients who received at least 1 dose of bardoxolone methyl) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study | Bardoxolone Methyl | Number and percent of participants with at least one adverse event | 232 | Participants | |
| Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study | Bardoxolone Methyl | Number and percent of participants with a related adverse event | 89 | Participants | |
| Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study | Bardoxolone Methyl | Number and percent of participants with a serious adverse event | 106 | Participants | |
| Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study | Bardoxolone Methyl | Number and percent of participants with worst adverse event severity of mild | 42 | Participants | |
| Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study | Bardoxolone Methyl | Number and percent of participants with worst adverse event severity of moderate | 96 | Participants | |
| Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study | Bardoxolone Methyl | Number and percent of participants with worst adverse event severity of severe | 94 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bardoxolone Methyl | 261 | |
| Overall Study | COMPLETED | Bardoxolone Methyl | 0 | |
| Overall Study | NOT COMPLETED | Bardoxolone Methyl | 261 |
Source ClinicalTrials.gov
Adverse events190
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 | Iron deficiency anaemia | Blood and lymphatic system disorders | Bardoxolone Methyl | 14 | 261 | |
| other | Palpitations | Cardiac disorders | Bardoxolone Methyl | 12 | 261 | |
| other | Abdominal pain | Gastrointestinal disorders | Bardoxolone Methyl | 10 | 261 | |
| other | Constipation | Gastrointestinal disorders | Bardoxolone Methyl | 11 | 261 | |
| other | Diarrhoea | Gastrointestinal disorders | Bardoxolone Methyl | 41 | 261 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Bardoxolone Methyl | 13 | 261 | |
| other | Nausea | Gastrointestinal disorders | Bardoxolone Methyl | 31 | 261 | |
| other | Vomiting | Gastrointestinal disorders | Bardoxolone Methyl | 12 | 261 | |
| other | Asthenia | General disorders | Bardoxolone Methyl | 6 | 261 | |
| other | Fatigue | General disorders | Bardoxolone Methyl | 19 | 261 |
1 to 10 of 190Source ClinicalTrials.gov
See all 190 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bardoxolone Methyl | 17 | 261 |
| Total, other adverse events | Bardoxolone Methyl | 198 | 261 |
| Total, serious adverse events | Bardoxolone Methyl | 106 | 261 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41223909 | DERIVED |
Source PubMed
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03068130
GET https://conductscience.org/api/trials/v1/NCT03068130/events?page=2