Efficacy of Ezetimibe/Simvastatin 10/20 mg and MK0524A (1-2 g/Day) in Mixed Hyperlipidemia and Two or More Risk Factors

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Overview

To measure the percentage of patients who achieve all the treatment lipid goals being treated with ezetimibe/simvastatin 10/20 with or without MK0524A (1-2 g/day).

Patients will receive placebo for 4 weeks, then Vytorin 10/20 mg for 6 weeks, if efficacy of treatment is achieved, they will continue with Vytorin 10/20 mg + placebo for 12 more weeks, if not achieved, will receive Vytorin 10/20 mg + MK0524A 1 gr for 6 weeks, if efficacy achieved will continue with Vytorin 10/20 mg + MK0524A 1 gr + placebo; if not achieved, will receive Vytorin 10/20 mg + MK0524A 2 gr for 6 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Cardiovascular Diseases Hyperlipidemia

Interventions

ezetimibe/simvastatin 10/20 mg + placeboDRUG

Patients will receive placebo (sugar tablets) for up to 22 weeks.

ezetimibe/simvastatin 10/20 mg + MK0524ADRUG

ezetimibe (+) simvastatin 10/20 mg for 18 weeks. Tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient Without Ischemic Cardiovascular Disease Who During The Treatment With Statin Have LDL-C \<130 Mg/Dl at Visit 1 Or Within The 6 Month Period Before Visit 1 Exclusion criteria: * The use of any other lipid lowering agent * Life expectancy lower than a year. * Any condition that may interfere with the adherence to the study protocol

Outcomes

Primary Outcomes

Lipid parameters efficacy comparing ezetimibe/simvastatin alone vs. ezetimibe/simvastatin plus MK0524A (CORDAPTIVE)

Time frame: 18 Week(s)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.