Effects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated with Lomitapide in Usual Care (CAPTURE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20500
• EU PAS number:
  EUPAS7957
• Study ID:
  20500
• Official title and acronym:
  Effects of Lomitapide on Carotid and Aortic Atherosclerosis in Patients Treated with Lomitapide in Usual Care (CAPTURE)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  France

  Italy

  Netherlands

  United States
• Study description:
  The study is designed to evaluate the effects of lomitapide on carotid and aortic atherosclerosis in patients treated with lomitapide in usual clinical practice and who are enroled in the Lomitapide Observational Worldwide Evaluation Registry (LOWER).
• Study status:
  Planned

Research institution and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

United BioSource Corporation (UBC)

Switzerland

Pr Eric Bruckert APHO, Pitié Salpeêtrière, 83 Bd de l’hopital 75013 Paris, France, Pr E.S.G Stroes AMC Medical Research B.V.Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands, Pr Claudia Stefanutti Lipid Clinic and Atherosclerosis Prevention Centre, ‘Umberto I’ Hospital, Dept of Molecular Medicine, ‘Sapienza’ University of Rome, Viale del Policlinico 155 00161, Rome, Italy

Study timelines

Date when funding contract was signed

Planned: 17/01/2014

Actual: 16/09/2014

Study start date

Planned: 30/04/2015

Data analysis start date

Planned: 01/01/2016

Date of final study report

Planned: 26/04/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Aegerion Pharmaceuticals

Study protocol

Initial protocol

aegr-733-028-protocol 2 Apr 2014

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)