Summary

for people ages 18-85 (full criteria)
at UCLA UCSD UC Davis
study started
estimated completion:
David Poch (ucsd) Rajan Saggar (ucla) Roblee Allen (ucdavis) Ronald J. Oudiz (ucla)

Description

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.

Official Title

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

Details

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.

Keywords

Pulmonary Hypertension Pulmonary Arterial Hypertension PH PAH Bardoxolone methyl 6-minute walk distance CDDO-ME RTA 402 LARIAT CATALYST RANGER Hypertension Hypertension, Pulmonary Bardoxolone methyl 10 mg

Eligibility

You can join if…

Open to people ages 18-85

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • David Geffen School of Medicine UCLA not yet accepting patients
    Los Angeles California 90095 United States
  • University of California Davis Medical Center - Division of Pulmonary and Critical Care accepting new patients
    Sacramento California 95817 United States
  • Harbor - UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • VA Healthcare System of Greater Los Angeles accepting new patients
    Los Angeles California 90073 United States
  • Cedars Sinai Medical Center accepting new patients
    Beverly Hills California 90211 United States

Lead Scientists

  • David Poch (ucsd)
    Associate Clinical Professor, Medicine. Authored (or co-authored) 14 research publications
  • Rajan Saggar (ucla)
    Assistant Professor, Medicine. Authored (or co-authored) 70 research publications
  • Roblee Allen (ucdavis)
    Professor, Pulmonary, Critical Care, and Sleep Medicine
  • Ronald J. Oudiz (ucla)
    Professor, Cardiology. Authored (or co-authored) 76 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Reata Pharmaceuticals, Inc.
ID
NCT03068130
Phase
Phase 3
Study Type
Interventional
Last Updated