Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: ezetimibe/simvastatin 10/40 (Drug); atorvastatin 40 mg (Drug); atorvastatin 20 mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
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.
Clinical Details
Official title: A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus Doubling the Baseline Dose of Atorvastatin
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percent Change From Baseline in Low Density Lipoprotein (LDL)-C
Secondary outcome: Number of Participants Reaching LDL-C Target Goals of <70 mg/dLNumber of Participants Reaching LDL-C Target Goal <77 mg/dL Number of Participants Reaching LDL-C Target Goal <100 mg/dL Percent Change From Baseline in Total Cholesterol Percent Change From Baseline in Triglycerides Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol Percent Change From Baseline in Non-HDL Cholesterol Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio Percent Change From Baseline in Apolipoprotein B Percent Change From Baseline in Apolipoprotein A-1 Percent Change From Baseline in Apolipoprotein B/A-1 Ratio Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP)
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: November 2008
Last updated: December 10, 2014
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