A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorBristol-Myers Squibb
About this trial
The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult participants 19 years of age or older
Participants who receive mavacamten according to the approved product label
Participants who sign the informed consent form
Disqualifiers
Participants who are prescribed mavacamten for therapeutic indications not approved in Korea
Participants for whom mavacamten is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety
Trial population
Adult participants diagnosed with symptomatic oHCM who will receive mavacamten according to the approved product label
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Mavacamten
DrugAccording to approved product label
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Participants receiving mavacamten for oHCM1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with adverse events
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov