Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT (NCT02036970) | Clinical Trial Compass
CompletedPhase 2
Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT
United States166 participantsStarted 2014-05-31
Plain-language summary
This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with pulmonary hypertension to determine the recommended dose range, evaluate the change from baseline in 6-minute walk distance (6MWD) and determine the effect of Bardoxolone methyl in pulmonary hypertension associated with connective tissue disease, interstitial lung disease, and idiopathic etiologies, including subsets of patients with WHO Group III or WHO Group V PH following 16 weeks of study participation.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adult male and female patients ≥ 18 to ≤ 75 years of age upon study consent;
✓. BMI \> 18.5 kg/m²
✓. Symptomatic pulmonary hypertension WHO class II and III;
✓. WHO Group I, III, or V PH according to the following criteria:
✓. If diagnosed with WHO Group I PAH, then on of the following subtypes:
✓. If WHO Group III PH then primary diagnosis must be one of the following subtypes:
✓. If WHO Group V PH then patient must be diagnosed with sarcoidosis;
✓. Had a diagnostic right heart catheterization performed and documented within 36 months prior to Day 1 that confirmed a diagnosis of PH
Exclusion criteria
✕. Participation in other interventional clinical studies involving pharmaceutical products being tested or used in a way different from the approved form or when used for an unapproved indication within 30 days prior to Day 1;
What they're measuring
1
Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo
✕. Initiation of an exercise program for cardio-pulmonary rehabilitation within 3 months (90 days) prior to Day 1 or planned initiation during Part 1 of the study;
✕. Stopped receiving any PH chronic therapy within 60 days prior to Day 1;
✕. Requirement for receipt of intravenous inotropes within 30 days prior to Day 1;
✕. Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) \> 160 mm Hg or sitting diastolic blood pressure \> 100 mm Hg during Screening after a period of rest;
✕. Has systolic BP \< 90 mm Hg during Screening after a period of rest;
✕. WHO Group III or V patients who at rest require supplemental oxygen at a rate of \>4 L/min and have peripheral capillary oxygen saturation levels \<92%;
✕. Has a history of clinically significant left-sided heart disease and/or clinically significant cardiac disease,including but not limited to any of the following: