CLINICAL TRIALS PROFILE FOR MAVACAMTEN
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All Clinical Trials for mavacamten
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT03442764 ↗ | A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) | Completed | MyoKardia, Inc. | Phase 2 | 2018-03-30 | This is a multicenter, exploratory, randomized, double-blind study of the administration of mavacamten in 60 participants with symptomatic nHCM randomized to receive a 16-week course of mavacamten doses titrated to achieve 1 of 2 target drug concentrations. |
| NCT03470545 ↗ | Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy | Completed | MyoKardia, Inc. | Phase 3 | 2018-05-29 | This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten. |
| NCT03496168 ↗ | Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER | Active, not recruiting | MyoKardia, Inc. | Phase 2 | 2018-04-26 | This is a multicenter open-label study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM) who previously participated in study MYK-461-004 (PIONEER-HCM). |
| NCT03723655 ↗ | A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM | Enrolling by invitation | MyoKardia, Inc. | Phase 2/Phase 3 | 2018-10-05 | Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study. Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study. Note: Approximately 30 centers overlap between MAVERICK and EXPLORER. |
| NCT04349072 ↗ | A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy | Active, not recruiting | MyoKardia, Inc. | Phase 3 | 2020-06-26 | This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures performed in subjects with symptomatic obstructive hypertrophic cardiomyopathy (oHCM [also known as HOCM]) who are eligible for SRT based on ACCF/AHA 2011 and/or ESC 2014 guidelines. |
| NCT04766892 ↗ | A Study of Mavacamten in Participants With HFpEF and Chronic Elevation of cTnI and/or NT-proBNP | Recruiting | MyoKardia, Inc. | Phase 2 | 2021-03-30 | This is a Phase 2a proof-of-concept study to assess safety, tolerability, and preliminary efficacy of mavacamten treatment on biomarkers levels in participants with heart failure with preserved ejection fraction (HFpEF) and chronic elevation of cTnI and/or NT-proBNP. Data from this study will inform future study designs of mavacamten in participants with HFpEF. |
| NCT05135871 ↗ | Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects | Recruiting | LianBio LLC | Phase 1 | 2021-10-31 | Mavacamten is a small-molecule allosteric inhibitor of cardiac myosin that reversibly inhibits its binding to cardiac actin, thereby relieving systolic hypercontractility and improving ventricular compliance. This is an open-label, parallel-group, single-center Phase 1 clinical study. Healthy adult Chinese subjects with different CYP2C19 genotypes (Cohort 1 and Cohort 2: CYP2C19 UM, RM, or NM; Cohort 3: CYP2C19 IM; Cohort 4: CYP2C19 PM) will be included and administered with a single fasted oral dose of mavacamten to evaluate its PK profile. Up to 44 subjects will be enrolled in this study. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for mavacamten
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