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OpenTrials
Completed

NCT Number: NCT00782184

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ezetimibe/simvastatin 10/40

Drug

ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.

Other names: Vytorin

Atorvastatin 40 mg

Drug

atorvastatin 40 mg tablet once daily for 6 weeks

Other names: Lipitor

Atorvastatin 20 mg

Drug

All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization

Other names: Lipitor

Primary outcomes

  1. Percent Change From Baseline in Low Density Lipoprotein (LDL)-C

    Time frame: Baseline (Treatment Day 1), Treatment Week 6

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 31, 2008
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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