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Completed

NCT Number: NCT01154036

MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)

This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

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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

About this study

This is a 18 week randomized, double-blind, active-controlled, multicenter study composed of a 6 week screening/run-in and 12 week double-blind treatment period (composed of 2 phases; each 6 weeks in duration). Only those participants who do not meet low density lipoprotein-cholesterol (LDL-C) goals at the end of Phase I (Week 6), were eligible to continue into Phase II (Week 12).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents
  • Patient is willing to maintain a cholesterol lowering diet during the study
  • Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study

Exclusion criteria

  • Patient is Asian
  • Patient routinely has more than 2 alcoholic drinks per day
  • Female patient is pregnant or breastfeeding
  • Patient has congestive heart failure
  • Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening
  • Patient has uncontrolled cardiac arrhythmias
  • Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption
  • Patient has uncontrolled high blood pressure
  • Patient has kidney disease
  • Patient has any disease known to influence blood lipid levels
  • Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation
  • Patient has poorly controlled or newly diagnosed diabetes
  • Patient is known to be HIV positive
  • Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers

Treatment and study plan

Ezetimibe 10 mg

Drug

atorvastatin

Drug

Comparator: Rosuvastatin

Drug

Primary outcomes

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

    Time frame: Baseline and Week 6 (end of Phase I )

    LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L).

Secondary outcomes

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

    Time frame: Baseline (Week 6) and Week 12

    LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L).

  2. Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I)

    Time frame: Week 6 (End of Phase I)

  3. Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II)

    Time frame: Week 12 (End of Phase II)

  4. Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I)

    Time frame: Week 6 (End of Phase I)

  5. Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II)

    Time frame: Week 12 (end of Phase II)

  6. Percent Change From Baseline in Total Cholesterol (TC) (Phase I)

    Time frame: Baseline and Week 6 (end of Phase I)

    TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

  7. Percent Change From Baseline in Total Cholesterol (TC) (Phase II)

    Time frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)

    TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

  8. Percent Change From Baseline in Triglycerides (TG) (Phase I)

    Time frame: Baseline and Week 6 (end of Phase I)

    TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.

  9. Percent Change From Baseline in Triglycerides (TG) (Phase II)

    Time frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)

    TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.

  10. Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I)

    Time frame: Baseline and Week 6 (end of Phase I)

    HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

  11. Percent Change From Baseline in HDL-C (Phase II)

    Time frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)

    HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

  12. Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I)

    Time frame: Baseline and Week 6 (end of Phase I)

    Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

  13. Percent Change From Baseline in Apo B (Phase II)

    Time frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)

    Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

  14. Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I)

    Time frame: Baseline and Week 6 (end of Phase I)

    Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

  15. Percent Change From Baseline in Apo A-I (Phase II)

    Time frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)

    Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

  16. Percent Change From Baseline in Non-HDL-C (Phase I)

    Time frame: Baseline and Week 6 (end of Phase I)

    Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

  17. Percent Change From Baseline in Non-HDL-C (Phase II)

    Time frame: Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II)

    Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

  18. Percent Change From Baseline in TC/HDL-C Ratio (Phase I)

    Time frame: Baseline and Week 6 (end of Phase I)

    TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

  19. Percent Change From Baseline in TC/HDL-C Ratio (Phase II)

    Time frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)

    TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

  20. Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase I)

    Time frame: Baseline and Week 6 (end of Phase I)

    LDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

  21. Percent Change From Baseline in LDL-C/HDL-C Ratio (Phase II)

    Time frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)

    LDL-C/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

  22. Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase I)

    Time frame: Baseline and Week 6 (end of Phase I)

    Apo B/Apo A-I ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

  23. Percent Change From Baseline in Apo B/Apo A-I Ratio (Phase II)

    Time frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)

    Apo B/Apo A-I Ratio calculated at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

  24. Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase I)

    Time frame: Baseline and Week 6 (end of Phase I)

    Non HDL-C/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4

  25. Percent Change From Baseline in Non-HDL-C/HDL-C Ratio (Phase II)

    Time frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)

    Non HDL-C/HDL-C Ratio calculated at baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6.

  26. Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) (Phase I)

    Time frame: Baseline and Week 6 (end of Phase I)

    hs-CRP measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.

  27. Percent Change From Baseline in Hs-CRP (Phase II)

    Time frame: Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II)

    hs-CRP measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled With Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2010
Registry last updated
Feb 9, 2022

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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