Health TrialsbyHealthPanel

Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan

ConditionObstructive Hypertrophic Cardiomyopathy (oHCM)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to assess the real-world effectiveness and safety of mavacamten in patients with obstructive hypertrophic cardiomyopathy (HCM) receiving mavacamten in Japan

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

The study population will consist of adults diagnosed with obstructive hypertrophic cardiomyopathy (oHCM) who initiate mavacamten treatment at medical institutions in Japan

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Mavacamten

    Drug

    According to the product label

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Cohort 11 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs) and/or serious AEs (SAEs)

Time frame
Up to 52 weeks
2

Actions taken after adverse events (AEs) and/or serious AEs (SAEs)

Time frame
Up to 52 weeks
3

Outcome of adverse events (AEs) and/or serious AEs (SAEs)

Time frame
Up to 52 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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