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Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER (RANGER)

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ClinicalTrials.gov Identifier: NCT03068130
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Bardoxolone methyl Phase 3

Detailed Description:

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.

Qualified patients will receive 10 mg of bardoxolone methyl once daily until the drug is available through commercial channels or until patient withdrawal, whichever is sooner. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Bardoxolone methyl
Capsules of Bardoxolone methyl
Other Name: RTA 402




Primary Outcome Measures :
  1. Long-term Safety [ Time Frame: Up to 5 years (December 2021) ]
    Long-term Safety as Measured by Incidence of Adverse Events During the maximum study duration of 5 years



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068130


Contacts
Contact: Lacey Powers (972) 865-2219 ranger@reatapharma.com

  Show 103 Study Locations
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.

Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03068130     History of Changes
Other Study ID Numbers: RTA 402-C-1602
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Reata Pharmaceuticals, Inc.:
Pulmonary Arterial Hypertension
Pulmonary Hypertension
PH
PAH
Bardoxolone methyl
6-minute walk distance
CDDO-ME
RTA 402
LARIAT
CATALYST
RANGER

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases