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

Status and phase: Withdrawn; Phase 4

Conditions: Hyperlipidemia; Cardiovascular Diseases

Treatments: Drug: ezetimibe/simvastatin 10/20 mg + MK0524A; Drug: ezetimibe/simvastatin 10/20 mg + placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00738985

2008_019

Details and patient eligibility

About

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).

Full description

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups, including a placebo group

ezetimibe/simvastatin 10/20 mg + placebo

Placebo Comparator group

Description:

The intervention consisted of an isocaloric diet, an exercise program (30 min/day of aerobic activity) and ezetimibe (+) simvastatin 10/20 mg + placebo for 12 weeks. Safety and efficacy parameters are measured at baseline and 12 weeks later

Treatment:

Drug: ezetimibe/simvastatin 10/20 mg + placebo

ezetimibe/simvastatin 10/20 mg + MK0524A

Active Comparator group

Description:

The intervention consisted of an isocaloric diet, an exercise program (30 min/day of aerobic activity) and ezetimibe/simvastatin 10/20 mg + MK0524A 1 gr for 6 weeks, if efficacy achieved will continue with ezetimibe (+) simvastatin 10/20 mg + MK0524A 1 gr + placebo; if not achieved, will receive ezetimibe (+) simvastatin 10/20 mg + MK0524A 2 gr for 6 weeks.

Treatment:

Drug: ezetimibe/simvastatin 10/20 mg + MK0524A