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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/dL

Number 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

Page last updated: August 23, 2015

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