Pulmonary Hypertension MedDRA version: 21.1 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Bardoxolone Methyl
Product Code: RTA 402
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: bardoxolone methyl
CAS Number: 218600-53-4
Current Sponsor code: RTA 402
Other descriptiv
Sponsors
Reata Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Treatment-compliant patients who are participating in qualifying ongoing studies and have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 373 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 41
Exclusion criteria
Exclusion criteria: 1. Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication 2. Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl 3. Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while taking study drug 4. Women who are pregnant or breastfeeding 5. Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason 6. Known hypersensitivity to any component of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide continuing open-label treatment with bardoxolone methyl as part of this extended access program while collecting ongoing safety and tolerability data of bardoxolone methyl;Secondary Objective: Not Applicable ;Primary end point(s): Frequency, intensity, and relationship to study drug of adverse events (AEs) and serious adverse events (SAEs), and change from baseline in the following assessments: physical examinations, vital sign measurements, BNP, N-terminal pro-brain natriuretic peptide (NT-proBNP), and weight;Timepoint(s) of evaluation of this end point: When bardoxolone methyl becomes commercially available or when the patient withdraws from the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable ;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, Czech Republic, Germany, Israel, Japan, Mexico, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactStudy Manager
Reata Pharmaceuticals, Inc.
Outcome results
None listed