Assessing the safety of mavacamten in Korean patients with obstructive hypertrophic cardiomyopathy
CAMZYOS® (Mavacamten) Post-Marketing Surveillance in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
Bristol-Myers Squibb · NCT06146660
This study is testing how safe the medication mavacamten is for adults in Korea who have symptoms of obstructive hypertrophic cardiomyopathy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb (industry) |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT06146660 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the real-world safety of mavacamten in adult patients suffering from symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in Korea. Participants will be enrolled if they receive at least one dose of mavacamten as per the approved product label. The study will gather data on the safety profile of the medication in a real-world setting, providing insights into its effects and tolerability among the target population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 years or older who are receiving mavacamten for symptomatic obstructive hypertrophic cardiomyopathy.
Not a fit: Patients who are prescribed mavacamten for unapproved therapeutic indications or those for whom it is contraindicated will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety of mavacamten, potentially improving treatment options for patients with obstructive hypertrophic cardiomyopathy.
How similar studies have performed: While this study focuses on the safety of mavacamten in a specific population, similar studies have shown promising results in assessing the safety and efficacy of treatments for hypertrophic cardiomyopathy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Seoul and 1 other locations
- Local Institution - 0001 — Seoul, South Korea (TERMINATED)
- Novotech Laboratory Korea Co., Ltd. — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Hypertrophic Cardiomyopathy