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

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ClinicalTrials.gov Identifier: NCT00782184
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : October 31, 2011
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in Low Density Lipoprotein (LDL)-C [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

Secondary Outcome Measures :
  1. Number of Participants Reaching LDL-C Target Goals of <70 mg/dL [ Time Frame: Treatment Week 6 ]
    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.

  2. Number of Participants Reaching LDL-C Target Goal <77 mg/dL [ Time Frame: Treatment Week 6 ]
    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.

  3. Number of Participants Reaching LDL-C Target Goal <100 mg/dL [ Time Frame: Treatment Week 6 ]
    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.

  4. Percent Change From Baseline in Total Cholesterol [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]
  5. Percent Change From Baseline in Triglycerides [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]
  6. Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]
  7. Percent Change From Baseline in Non-HDL Cholesterol [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]
  8. Percent Change From Baseline in LDL-Cholesterol/HDL-Cholesterol Ratio [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]
  9. Percent Change From Baseline in Total Cholesterol/HDL-Cholesterol Ratio [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]
  10. Percent Change From Baseline in Non-HDL Cholesterol/HDL-Cholesterol Ratio [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]
  11. Percent Change From Baseline in Apolipoprotein B [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]
  12. Percent Change From Baseline in Apolipoprotein A-1 [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]
  13. Percent Change From Baseline in Apolipoprotein B/A-1 Ratio [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]
  14. Percent Change From Baseline in High-sensitivity C-Reactive Protein (Hs-CRP) [ Time Frame: Baseline (Treatment Day 1), Treatment Week 6 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00782184


Sponsors and Collaborators
Organon and Co
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00782184    
Other Study ID Numbers: 0653A-134
2008_576
First Posted: October 31, 2008    Key Record Dates
Results First Posted: October 31, 2011
Last Update Posted: February 14, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Simvastatin
Ezetimibe
 Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors