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Fixed Dose Combination drugs for Secondary Cardiovascular Prevention

Objective

Cardiovascular diseases (CVD) are the leading cause of death worldwide, and their incidence is increasing sharply in developing countries. Two insufficiently addressed factors contribute to increased morbidity and mortality, threatening the effectiveness of any health system: poor patient adherence to treatment, and limited access to medication in resource-poor countries and regions. To address these issues, FOCUS aims to test the Fixed-Dose-Combination (FDC) concept for CVD prevention and treatment in populations with diverse socio-economic characteristics. The FOCUS FDC pill developed by the consortium is a single-day pill containing three active components of well-demonstrated efficacy. It can be produced and administrated at a much lower cost than conventional multi-pill equivalents and is thus especially suitable for widespread use in resource-poor countries. The FDC pill will be tested in two complementary controlled clinical studies: a descriptive non-interventional study followed by an interventional randomized trial. The studies will analyze data collected at 40 clinical sites in Europe and 40 sites in three middle-income developing countries. FOCUS is an international collaboration between research institutes, clinicians, pharma industry, SMEs and scientific organisations. It aims to establish a proof of concept of FDC efficacy for secondary CVD prevention, and a better understanding of socio-economic factors that influence access and adherence to CVD treatment. Based on the project results FOCUS will publish recommendations for the use of this medication to improve patient adherence and access to CVD prevention medication in developing countries and beyond. A successful project will directly contribute to improved use of clinical research findings for treatment of CVD diseases and to creating equitable access to a more efficient CVD prevention medication for patients in developed and resource-poor countries.

Field of science

  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug
  • /social sciences/sociology/demography/mortality
  • /medical and health sciences/clinical medicine/cardiology/cardiovascular diseases

Call for proposal

FP7-HEALTH-2009-single-stage
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III (F.S.P.)
Address
Calle Melchor Fernandez Almagro 3
28029 Madrid
Spain
Activity type
Research Organisations
EU contribution
€ 497 250
Administrative Contact
Luz álvarez (Ms.)

Participants (8)

ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Italy
EU contribution
€ 500 000
Address
Via Mario Negri 2
20156 Milano
Activity type
Research Organisations
Administrative Contact
Maria Grazia Pezzoni (Ms.)
DAMIC SRL
Argentina
EU contribution
€ 1 290 067
Address
Avenida Colon 2057
X5003DCE Cordoba
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Soledad Santirso (Ms.)
FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA
Spain
EU contribution
€ 482 878
Address
Carrer Rossello 149
08036 Barcelona
Activity type
Research Organisations
Administrative Contact
Aguado Fernando (Mr.)
ARTTIC
France
EU contribution
€ 174 999
Address
Rue Du Dessous Des Berges 58A
75013 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Eric Papon (Dr.)
FEDERACION ARGENTINA DE CARDIOLOGIA
Argentina
EU contribution
€ 20 250
Address
Bulnes 1004
1176 Buenos Aires
Activity type
Other
Administrative Contact
Luis Guzmán (Dr.)
WORLD HEART FEDERATION
Switzerland
EU contribution
€ 29 555
Address
Rue Des Battoirs 7
1211 Geneva
Activity type
Other
Administrative Contact
Sara Ramsey (Ms.)
INSTITUTO DE SALUD CARLOS III
Spain
EU contribution
€ 5 000
Address
Monforte De Lemos 5
28029 Madrid
Activity type
Research Organisations
Administrative Contact
Inmaculada Pastor (Ms.)
FERRER INTERNATIONAL
Spain
Address
Avenida Diagonal 549
08029 Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Joan Fanes (Mr.)