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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03068130




Registration number
NCT03068130
Ethics application status
Date submitted
22/02/2017
Date registered
1/03/2017
Date last updated
6/02/2024

Titles & IDs
Public title
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
Scientific title
An Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension
Secondary ID [1] 0 0
RTA 402-C-1602
Universal Trial Number (UTN)
Trial acronym
RANGER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bardoxolone methyl

Experimental: Bardoxolone methyl 10 mg - Bardoxolone methyl will be administered orally once daily at 10 mg until it becomes commercially available. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.


Treatment: Drugs: Bardoxolone methyl
Capsules of Bardoxolone methyl
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study
Timepoint [1] 0 0
From time of first dose until the final visit, up to 172 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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;
* Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl;
* 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;
* Women who are pregnant or breastfeeding;
* 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;
* Known hypersensitivity to any component of the study drug

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2020
Sample size
Target
Accrual to date
Final
261
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [4] 0 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Kentucky
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Maine
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Massachusetts
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Michigan
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Missouri
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Texas
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Utah
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Wisconsin
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Argentina
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Ciudad Autónoma De BuenosAires
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Argentina
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Mar Del Plata
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Argentina
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Cordoba
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Argentina
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Corrientes
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Rosario
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Argentina
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Santa Fe
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Belgium
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Vlaams Brabant
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Belgium
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Brussels
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Brazil
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São Paulo
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Canada
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Alberta
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British Columbia
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Ontario
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Canada
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Quebec
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Czechia
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Prague
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Germany
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Dresden
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Germany
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Hamburg
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Germany
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Heidelberg
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Japan
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Bunkyo-ku
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Mitaka-shi
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Japan
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Okayama
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Japan
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Chiba
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Japan
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Sapporo
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Japan
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Sendai-shi
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Japan
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Suita
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Mexico
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Distrito Federal
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Mexico
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Monterrey
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Mexico
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Nuevo Leon
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Netherlands
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Noord-Holland
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Philippines
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Metro Manila
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Philippines
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Makati
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Manila
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Spain
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Cantabria
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Toledo
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United Kingdom
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Glasgow
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Reata, a wholly owned subsidiary of Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.
Trial website
https://clinicaltrials.gov/study/NCT03068130
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03068130