This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C \>/= 100 mg/dL (2.6 mmol/L) or non-HDL-C \>/=130 mg/dL (3.4 mmol/L).
The trial was terminated prematurely on November 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents. These indicated that bococizumab was not likely to provide value to patients, physicians, or shareholders. The decision was not based on a recommendation by the independent Data Monitoring Committee to stop the program.
150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
Bahía Blanca, Buenos Aires, Argentina
Bahía Blanca, Buenos Aires, Argentina
C.a.b.a., Buenos Aires, Argentina
Ciudad Autonoma de B. Aires, Buenos Aires, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Coronel Suárez, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Lanús Este, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Ramos Mejía, Buenos Aires, Argentina
Zárate, Buenos Aires, Argentina
C.a.b.a, Buenos Aires F.D., Argentina
C.a.b.a, C.a.b.a., Argentina
Villa María, Córdoba Province, Argentina
Godoy Cruz, Mendoza Province, Argentina
Ciudadela, PCIA de Buenos Aires, Argentina
Morón, PCIA de Buenos Aires, Argentina
Resistencia, PCIA de Chaco, Argentina
Formosa, PCIA de Formosa, Argentina
Santa Fe, PCIA de Santa FE, Argentina
Santa Fe, PCIA de Santa FE, Argentina
Santa Fe, PCIA de Santa FE, Argentina
San Miguel de Tucumán, PCIA de Tucuman, Argentina
Rosario, Pcia. de Santa FE, Argentina
Rosario, Santa Fe Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Ciudad Autonoma de B. Aires, Argentina
Ciudad Autonoma de B. Aires, Argentina
Corrientes, Argentina
Córdoba, Argentina
Córdoba, Argentina
Córdoba, Argentina
Córdoba, Argentina
Córdoba, Argentina
Córdoba, Argentina
Córdoba, Argentina
Mendoza, Argentina
Salta, Argentina
Salta, Argentina
San Luis, Argentina