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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014