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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-09-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ezetimibe/simvastatin 10/20 mg + placebo

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

Group Type PLACEBO_COMPARATOR

ezetimibe/simvastatin 10/20 mg + placebo

Intervention Type DRUG

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

ezetimibe/simvastatin 10/20 mg + MK0524A

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.

Group Type ACTIVE_COMPARATOR

ezetimibe/simvastatin 10/20 mg + MK0524A

Intervention Type DRUG

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

Interventions

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ezetimibe/simvastatin 10/20 mg + placebo

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

Intervention Type DRUG

ezetimibe/simvastatin 10/20 mg + MK0524A

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

Intervention Type DRUG

Other Intervention Names

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No other drug is used per protocol in this study arm Vytorin MK0653A

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No