Meta-Analysis of Amputation Events from Clinical Trials DIA3008 (CANVAS), DIA4003 (CANVAS-R), and DNE3001 (CREDENCE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34354
• EU PAS number:
  EUPAS29875
• Study ID:
  34354
• Official title and acronym:
  Meta-Analysis of Amputation Events from Clinical Trials DIA3008 (CANVAS), DIA4003 (CANVAS-R), and DNE3001 (CREDENCE)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Belgium

  Brazil

  Canada

  China

  Colombia

  Czechia

  Estonia

  France

  Germany

  Hungary

  India

  Israel

  Italy

  Korea, Republic of

  Luxembourg

  Malaysia

  Mexico

  Netherlands

  New Zealand

  Norway

  Russian Federation

  Spain

  Sweden

  Taiwan

  Ukraine

  United Kingdom

  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

Johnson & Johnson

Study timelines

Date when funding contract was signed

Planned: 23/07/2018

Actual: 23/07/2018

Study start date

Planned: 26/04/2019

Actual: 26/04/2019

Date of final study report

Planned: 01/08/2019

Actual: 20/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

JANSSEN-CILAG INTERNATIONAL NV

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)