Conditions: Hypercholesterolemia Dyslipidemia
Keywords: Hypercholesterolemia Dyslipidemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 129
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the non-inferiority between two different FDC (fixed-dose combination), measuring LDL-Cholesterol levels, in high risk patients with primary hypercholesterolemia or mixed dyslipidemia.

Detailed description:
The primary efficacy variable was the percentage of LDL-C variation at the end of nine weeks of treatment, compared to baseline (pre-randomization), in participants who achieved LDL \<100 mg/dL were considered to have been successfully treated.

Arms:
arm 1: Participants received Rosuvastatin 10 mg+ Ezetimibe 10 mg tablet orally once daily for 5 weeks and after a LDL evaluation if it level was \<100 mg/dL the dose was maintained for more 4 weeks. However, if the LDL-C levels was ≥100 mg/dL, the dose was adjusted to Rosuvastatin 20 mg+ Ezetimibe 10mg tablet orally once daily for more 4 weeks. arm 2: Participants received Simvastatin 20 mg+ Ezetimibe 10 mg tablet orally once daily for 5 weeks and after a LDL evaluation if it level was \<100 mg/dL the dose was maintained for more 4 weeks. However, if the LDL-C levels was ≥100 mg/dL, the dose was adjusted to Simvastatin 40 mg + Ezetimibe 10mg tablet orally once daily for more 4 weeks.

Interventions: intervention 1: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation. intervention 2: Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.
Intervention descriptions: intervention 1: Tables containing: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation. intervention 2: Tables containing: Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.

Protocol document: