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 States, Germany166 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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline Though Week 16 in 6-Minute Walk Distance (6MWD) for Bardoxolone Methyl Compared to Placebo
. 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;
. 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: