Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT
NCT02036970 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166
Last updated 2025-06-10
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.
Conditions
- Pulmonary Arterial Hypertension
- Pulmonary Hypertension
- Interstitial Lung Disease
- Idiopathic Interstitial Pneumonia
- Idiopathic Pulmonary Fibrosis
- Sarcoidosis
- Respiratory Bronchiolitis Associated Interstitial Lung Disease
- Desquamative Interstitial Pneumonia
- Cryptogenic Organizing Pneumonia
- Acute Interstitial Pneumonitis
- Idiopathic Lymphoid Interstitial Pneumonia
- Idiopathic Pleuroparenchymal Fibroelastosis
Interventions
- DRUG
-
Bardoxolone methyl
- DRUG
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-31
- Primary Completion
- 2018-01-19
- Completion
- 2018-05-16
Countries
- United States
- Germany
Study Locations
More Related Trials
-
Effect iNO on Functional Respiratory Imaging in Subjects With WHO Group 3 Pulmonary Hypertension With COPD on Oxygen
NCT03135860 ·Status: TERMINATED ·Phase: EARLY_PHASE1
-
Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH
NCT03556020 ·Status: TERMINATED ·Phase: PHASE2
-
Two-Part Dose-Confirming Study of Pulsed Inhaled Nitric Oxide in Subjects With WHO Group 3 Pulmonary Hypertension Associated With COPD
NCT01728220 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE)
NCT04712669 ·Status: COMPLETED ·Phase: PHASE2
-
A Dose Escalation Study to Evaluate the Effect of RT234 in Subjects With Pulmonary Arterial Hypertension
NCT05343637 ·Status: COMPLETED ·Phase: PHASE2
-
Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study
NCT04266197 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of Inhaled Treprostinil Sodium for the Treatment of Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
NCT00703339 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis
NCT00071461 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Spironolactone for Pulmonary Arterial Hypertension
NCT01712620 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Mosliciguat in PH-ILD
NCT06635850 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH
NCT02725372 ·Status: TERMINATED ·Phase: PHASE3
-
Frespaciguat (MK-5475) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) (MK-5475-006)
NCT04370873 ·Status: COMPLETED ·Phase: PHASE1
-
ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
NCT00879229 ·Status: TERMINATED ·Phase: PHASE3
-
Efficacy and Safety of Riociguat in Patients With Symptomatic Pulmonary Hypertension (PH) Associated With Idiopathic Interstitial Pneumonias (IIP)
NCT02138825 ·Status: TERMINATED ·Phase: PHASE2
-
A Multinational, Multicenter, Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor
NCT01458236 ·Status: WITHDRAWN ·Phase: PHASE3
-
Bioenergetic Effect of Pioglitazone in CLD-PH
NCT06336798 ·Status: RECRUITING ·Phase: PHASE2
-
A Phase 2 Study to Determine the Safety and Efficacy of AIR001 in Subjects With Pulmonary Arterial Hypertension (PAH)
NCT01725256 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489
NCT07073820 ·Status: RECRUITING ·Phase: PHASE2
-
Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)
NCT01966302 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of AZD3427 in Participants With Heart Failure and Pulmonary Hypertension Group 2
NCT05737940 ·Status: COMPLETED ·Phase: PHASE2
-
An Open-Label Study to Evaluate the Safety and Efficacy of PRX-08066 in Patients With Pulmonary Hypertension and Chronic Obstructive Pulmonary Disease
NCT00677872 ·Status: TERMINATED ·Phase: PHASE2
-
Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan
NCT00625469 ·Status: WITHDRAWN ·Phase: PHASE4
-
Study of ACT-293987 (NS-304) in Pulmonary Arterial Hypertension (PAH)
NCT00993408 ·Status: COMPLETED ·Phase: PHASE2
-
Bronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial Hypertension
NCT02782052 ·Status: WITHDRAWN ·Phase: PHASE3
-
Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)
NCT01437878 ·Status: TERMINATED ·Phase: PHASE2