Meta-analysis to assess cardiovascular safety of mavacamten (CV027-1148)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000234
• EU PAS number:
  EUPAS1000000234
• Study ID:
  1000000234
• Official title and acronym:
  Meta-analysis to assess cardiovascular safety of mavacamten (CV027-1148)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  Brazil

  Canada

  Chile

  China

  Denmark

  Finland

  France

  Germany

  Greece

  Hungary

  India

  Israel

  Italy

  Japan

  Korea, Democratic People's Republic of

  Netherlands

  Norway

  Poland

  Portugal

  Spain

  Switzerland

  United Kingdom

  United States
• Study description:
  This meta-analysis study will utilize the patient-level data from pre-existing secondary data sources (studies) from BMS clinical trial repository to assess the risk of major cardiovascular (CV) outcomes associated with mavacamten compared to placebo treatment in adult participants with symptomatic hypertrophic cardiomyopathy (HCM).
• Study status:
  Planned

Research institutions and networks

Institutions

Bristol-Myers Squibb (BMS)

Study timelines

Date when funding contract was signed

Actual: 13/06/2023

Study start date

Planned: 02/02/2025

Date of final study report

Planned: 01/02/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb (BMS) 100%

Study protocol

Initial protocol

CV0271148-protamend01_02Jul2024.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)