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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00782184
First received: October 29, 2008
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Drug: ezetimibe/simvastatin 10/40
Drug: atorvastatin 40 mg
Drug: atorvastatin 20 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent Change From Baseline in Low Density Lipoprotein (LDL)-C [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Reaching LDL-C Target Goals of <70 mg/dL [ Time Frame: Treatment Week 6 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Reaching LDL-C Target Goal <77 mg/dL [ Time Frame: Treatment Week 6 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Reaching LDL-C Target Goal <100 mg/dL [ Time Frame: Treatment Week 6 ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in Total Cholesterol [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Triglycerides [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non-HDL Cholesterol [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein B [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein A-1 [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein B/A-1 Ratio [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: November 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: ezetimibe/simvastatin 10/40
ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.
Other Name: Vytorin
Drug: atorvastatin 20 mg
All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization
Other Name: Lipitor
Active Comparator: 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
Drug: atorvastatin 40 mg
atorvastatin 40 mg tablet once daily for 6 weeks
Other Name: Lipitor
Drug: atorvastatin 20 mg
All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization
Other Name: Lipitor

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782184

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00782184     History of Changes
Other Study ID Numbers: MK-0653A-134, 2008_576
Study First Received: October 29, 2008
Results First Received: September 22, 2011
Last Updated: September 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Atorvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014