Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2023-11-09
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Pregnant or breastfeeding women exposed to mavacamten
Mavacamten
Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding
Interventions
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Mavacamten
Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding
Eligibility Criteria
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Inclusion Criteria
* At least 15 years of age or older at the time of enrollment
* Informed consent or institutional review board/ethics committee-approved waiver of informed consent
Exclusion Criteria
15 Years
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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The Mavacamten Pregnancy Surveillance Program, PPD Inc
Wilmington, North Carolina, United States
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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The Mavacamten Pregnancy Surveillance Program Resea PPD, Inc
Role: primary
Related Links
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BMS Clinical Trial Information
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CV027-014
Identifier Type: -
Identifier Source: org_study_id