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

Organon and Co250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

250

Conditions

Hypercholesterolemia

Interventions

ezetimibe/simvastatin 10/40DRUG

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

atorvastatin 40 mgDRUG

atorvastatin 40 mg tablet once daily for 6 weeks

atorvastatin 20 mgDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percent Change From Baseline in Low Density Lipoprotein (LDL)-C

Time frame: Baseline (Treatment Day 1), Treatment Week 6

Secondary Outcomes

Number of Participants Reaching LDL-C Target Goals of <70 mg/dL

Target LDL-C level of \< 70 mg/dL (1.81 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.

Time frame: Treatment Week 6

Number of Participants Reaching LDL-C Target Goal <77 mg/dL

Target LDL-C level of \< 77 mg/dL (2.00 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.

Time frame: Treatment Week 6

Number of Participants Reaching LDL-C Target Goal <100 mg/dL

Target LDL-C level of \< 100 mg/dL (2.59 mmol/L) at study endpoint after 6 weeks of treatment for the Full Analysis Set (FAS) population.

Time frame: Treatment Week 6

Percent Change From Baseline in Total Cholesterol

Time frame: Baseline (Treatment Day 1), Treatment Week 6

Percent Change From Baseline in Triglycerides

Time frame: Baseline (Treatment Day 1), Treatment Week 6

Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol

Time frame: Baseline (Treatment Day 1), Treatment Week 6

Percent Change From Baseline in Non-HDL Cholesterol

Time frame: Baseline (Treatment Day 1), Treatment Week 6

Data from ClinicalTrials.gov

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