ClinicalTrials.gg
RecruitingNCT06146660Updated Nov 6, 2024

A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

An observational study in Obstructive Hypertrophic Cardiomyopathy, sponsored by Bristol-Myers Squibb. Recruiting at 2 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.

Sponsored by Bristol-Myers Squibb · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 26 studies in Cardiomyopathy, Hypertrophic by Bristol-Myers Squibb — 9 open to participants now, 14 under way, 1 of them phase 3. Cardiomyopathy, Hypertrophic · Bristol-Myers Squibb.

Planned enrollment
4th of 15
600 · median 200
Started
2024
with 5 others
Observational
15 of 26
9 open now
Primary completion
2026-11
later than 4 of 13 live
Registered
12th of 26
by date

Among the 26 studies in Cardiomyopathy, Hypertrophic by Bristol-Myers Squibb, this one is the 4th largest by planned enrollment of the 15 observational ones that give a count, is one of 6 that started in 2024, is one of 15 observational ones, reaches primary completion later than 4 of the 13 other live ones, and was the 12th registered.

Cardiomyopathy, Hypertrophic

363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.

Browse Cardiomyopathy, Hypertrophic studies →

Open to participants now

9 of the 26 studies in Cardiomyopathy, Hypertrophic by Bristol-Myers Squibb are open now, in 12 countries. Recruiting first, the newest first:

3 more — sign in →

By country, each count listing its studies:

All 9 open studies →

Who these studies take

Of the 81 Cardiomyopathy, Hypertrophic studies recruiting now, 55 (68%) set no upper age limit and 8 (10%) stop at 75 or younger; 21 take children under 18; 13 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 26 studies in Cardiomyopathy, Hypertrophic by Bristol-Myers Squibb, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Obstructive Hypertrophic Cardiomyopathy
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult participants diagnosed with symptomatic oHCM who will receive mavacamten according to the approved product label

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult participants 19 years of age or older
  • Participants who receive mavacamten according to the approved product label
  • Participants who sign the form

Exclusion criteria

Exclusion Criteria:

  • Participants who are prescribed mavacamten for therapeutic indications not approved in Korea
  • Participants for whom mavacamten is as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants receiving mavacamten for oHCM

    Drug: Mavacamten

Interventions

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events

    Time frame: Up to 12 months

07

Study locations

1 of 2 sites recruiting
  • Local Institution - 0001
    Seoul, 06234, Korea, Republic of
    Terminated

    Not enrolling at this site.

  • Novotech Laboratory Korea Co., Ltd.
    Seoul, 06234, Korea, Republic of
    Recruiting
    • South Korea Generic Country, Site 0002 · Contact0000000000
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Nov 2026, 28 months after the start.

Of 82 observational studies under Cardiomyopathy, Hypertrophic, half reached primary completion within 85 months of starting (the median), counting those still running; a quarter within 43. This study's planned 28 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2023
First posted
Nov 27, 2023
StartActual
Jul 24, 2024
Primary completionEst.
Nov 30, 2026
CompletionEst.
Nov 30, 2026
Last update
Nov 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06146660
Responsible party
Sponsor
First posted
Nov 27, 2023
Start date
Jul 24, 2024
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Nov 6, 2024

Study contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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