Conditions: Hypercholesterolemia Diabetes Mellitus, Type 2 Coronary Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 93
Healthy volunteers: no

Brief summary:
This multicenter, randomized, double-blind, placebo-controlled study will assess, after 6 weeks of dosing, whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with doubling the dose of simvastatin to 40 mg alone in reducing low-density lipoprotein-cholesterol (LDL-C) concentrations and in achieving the National Cholesterol Expert Panel (NCEP) III LDL-C target goal of \<2.6 mmol/L (\<100 mg/dL) for subjects with diabetes mellitus and coronary heart disease.

Detailed description:

Arms:
arm 1: Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, open-label, 20-mg simvastatin tablet. arm 2: Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, open-label, 20-mg simvastatin tablet.

Interventions: intervention 1: Ezetimibe 10 mg intervention 2: Simvastatin 20 mg intervention 3: Ezetimibe Placebo intervention 4: Simvastatin 20 mg intervention 5: Simvastatin Placebo
Intervention descriptions: intervention 1: 1 x 10-mg tablet, provided as blinded study treatment intervention 2: 1 x 20-mg tablet, provided as open-label study treatment intervention 3: 1 tablet matching ezetimibe 10-mg tablet, provided as blinded study treatment intervention 4: 1 x 20-mg tablet, provided as blinded study treatment intervention 5: 1 tablet matching 20-mg simvastatin tablet, provided as blinded study treatment

Protocol document: