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

  • Interventional
  • Recruiting
  • NCT03068130
Eligibility Details Visit Clinicaltrials.gov

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

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.

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.

Gender
All

Age Group
18 Years to 85 Years

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT03068130

IRB#IRB17-0600

Lead SponsorReata Pharmaceuticals, Inc.

Lead PhysicianRemzi Bag

Collaborator(s)N/A

EligibilityAll
18 Years to 85 Years
Recruiting