Obstructive Hypertrophic CardiomyopathyNCT06146660
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
An observational study of Obstructive Hypertrophic Cardiomyopathy, run by Bristol-Myers Squibb at 2 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- Mavacamten
- How many people
- 600 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 24 Jul 2024to 30 Nov 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants diagnosed with symptomatic oHCM who will receive mavacamten according to the approved product label
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
First line of the email MUST contain NCT # and Site #. contact
South Korea2 sites, 1 recruiting
- Terminated
Local Institution - 0001
Seoul, 06234
- Recruiting
Novotech Laboratory Korea Co., Ltd.
Seoul, 06234
South Korea Generic Country, Site 0002, 0000000000
About this study
Official title: CAMZYOS® (Mavacamten) Post-Marketing Surveillance in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)
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.
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Being tested
- Mavacamten
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavacamtenDrug
According to approved product label
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving mavacamten for oHCM | Not described Receives: Drug: Mavacamten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start24 Jul 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146660
- Sponsor's protocol ID
- CV027-1089
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No