Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-09-30

Brief Summary

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Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.

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Detailed Description

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Conditions

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Hypercholesterolemia

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 10/40

Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period

Group Type EXPERIMENTAL

ezetimibe/simvastatin 10/40

Intervention Type DRUG

ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.

atorvastatin 20 mg

Intervention Type DRUG

All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization

atorvastatin 40 mg

Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period

Group Type ACTIVE_COMPARATOR

atorvastatin 40 mg

Intervention Type DRUG

atorvastatin 40 mg tablet once daily for 6 weeks

atorvastatin 20 mg

Intervention Type DRUG

All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization

Interventions

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ezetimibe/simvastatin 10/40

ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.

Intervention Type DRUG

atorvastatin 40 mg

atorvastatin 40 mg tablet once daily for 6 weeks

Intervention Type DRUG

atorvastatin 20 mg

All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization

Intervention Type DRUG

Other Intervention Names

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Vytorin Lipitor Lipitor

Eligibility Criteria

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Inclusion Criteria

* Participants who are either statin naive or on approved lipid lowering therapy for 6 weeks prior to study initiation
* Participant meets Adult Treatment Panel (ATP) III High Risk criteria

Exclusion Criteria

* Females who are pregnant or breastfeeding
* Participant consumes more than 14 alcoholic beverages per week
* Participant has been treated with an investigational drug within the last 30 days
* Participant has congestive heart failure (New York Heart Association \[NYHA\] Type III or IV)
* Participant has had gastric bypass
* Participant is newly diagnosed with type 1 or 2 diabetes
* Participant is Human Immunodeficiency Virus (HIV) positive
* Participant has a history of drug or alcohol abuse within the last 5 years

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No