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CompletedNCT00535405Updated May 16, 2024Results posted

A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

A Phase 3 interventional study of Atorvastatin 10 mg and Ezetimibe 10 mg/simvastatin 20 mg in Hypercholesterolemia, sponsored by Organon and Co. Completed. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,289
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • High Cholesterol
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 1,289 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient has a cholesterol level of 130 mg/dL or greater
  • Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study
  • Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines

Exclusion criteria

Exclusion Criteria:

  • Patient weighs less than 100 lbs
  • Patient has an allergy to ezetimibe, simvastatin or atorvastatin
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,289 participants (actual)

Study arms

  • Experimental
    1

    Each patient will receive 1 active treatment dose \& 2 Placebo (Pbo) doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

    Drug: Atorvastatin 10 mg

  • Experimental
    2

    Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

    Drug: Ezetimibe 10 mg/simvastatin 20 mg

  • Experimental
    3

    Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

    Drug: Atorvastatin 20 mg

  • Experimental
    4

    Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

    Drug: Ezetimibe 10 mg/simvastatin 40 mg

  • Experimental
    5

    Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

    Drug: Atorvastatin 40 mg

Interventions

  • DrugAtorvastatin 10 mg

    Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

  • DrugEzetimibe 10 mg/simvastatin 20 mg

    Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks

  • DrugAtorvastatin 20 mg

    Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

  • DrugEzetimibe 10 mg/simvastatin 40 mg

    Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks

  • DrugAtorvastatin 40 mg

    Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12

    Time frame: 12 weeks

  2. Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12

    Patients with AVD Who Achieved LDL-C \<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.

    Time frame: 12 Weeks

  3. Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12

    Time frame: 12 Weeks

  4. Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12

    Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.

    Time frame: 12 Weeks

  5. Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12

    Patients with AVD Who Achieved LDL-C \<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.

    Time frame: 12 Weeks

07

Results

Posted May 25, 2010

Participant flow

Phase III First Patient In 08-Nov-2007; Last Patient Last Visit 23-Mar-2009 Eligible patients include drug-naïve patients or patients rendered naïve with the appropriate prior washout at moderately high or high risk for coronary heart disease 65 years and older.

Participant flow — Overall Study
MilestoneAtorvastatin 10 mgEzetimibe 10 mg/Simvastatin 20 mgAtorvastatin 20 mgEzetimibe 10 mg/Simvastatin 40 mgAtorva 40 mg
Started257259259257257
Completed240233241235241
Not completed1726182216
Withdrew: Adverse event68386
Withdrew: Lost to follow-up13321
Withdrew: Physician decision32011
Withdrew: Protocol violation22210
Withdrew: Withdrawal by subject51110108

Outcome measures

PrimaryPercent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
Time frame:
Baseline and 12 weeks
Reported as:
Least squares mean · Percent change in LDL-C
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12
Percent change in LDL-CAtorvastatin 10 mgEzetimibe 10 mg/Simvastatin 20 mgAtorvastatin 20 mgEzetimibe 10 mg/Simvastatin 40 mgAtorva 40 mg
Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12-39.5 (-41.4 to -37.5)-54.2 (-56.1 to -52.2)-46.6 (-48.6 to -44.7)-59.1 (-61.0 to -57.1)-50.8 (-52.8 to -48.9)
Statistical analysis
  • Atorvastatin 10 mg vs Ezetimibe 10 mg/Simvastatin 20 mg · ANCOVA · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Mean difference (final values): -14.7 · 95% CI -17.5 to -12.0ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.
  • Ezetimibe 10 mg/Simvastatin 20 mg vs Atorvastatin 20 mg · ANCOVA · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Mean difference (final values): -7.5 · 95% CI -10.3 to -4.8ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.
  • Ezetimibe 10 mg/Simvastatin 40 mg vs Atorva 40 mg · ANCOVA · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Mean difference (final values): -8.2 · 95% CI -11.0 to -5.5ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.
SecondaryPercentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12
Time frame:
12 weeks
Reported as:
Mean · Percent of Patients
Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12
Percent of PatientsAtorvastatin 10 mgEzetimibe 10 mg/Simvastatin 20 mgAtorvastatin 20 mgEzetimibe 10 mg/Simvastatin 40 mgAtorva 40 mg
Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 129.9 ± 1.9251.3 ± 3.2826.1 ± 2.8568.2 ± 3.0338.1 ± 3.14
Statistical analysis
  • Atorvastatin 10 mg vs Ezetimibe 10 mg/Simvastatin 20 mg · Logistic Regression using GEE · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 12.62 · 95% CI 7.64 to 20.83Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
  • Ezetimibe 10 mg/Simvastatin 20 mg vs Atorvastatin 20 mg · Logistic Regression using GEE · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 3.83 · 95% CI 2.51 to 5.85Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
  • Ezetimibe 10 mg/Simvastatin 40 mg vs Atorva 40 mg · Logistic Regression using GEE · p = <0.001 · Ratio of odds: 3.66 · 95% CI 2.39 to 5.60Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
SecondaryPercentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12

Patients with AVD Who Achieved LDL-C \<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.

Time frame:
12 Weeks
Reported as:
Mean · Percent of Patients
Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
Percent of PatientsAtorvastatin 10 mgEzetimibe 10 mg/Simvastatin 20 mgAtorvastatin 20 mgEzetimibe 10 mg/Simvastatin 40 mgAtorva 40 mg
Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 1245.0 ± 3.2069.0 ± 3.0461.3 ± 3.1682.1 ± 2.5069.9 ± 2.97
Statistical analysis
  • Atorvastatin 10 mg vs Ezetimibe 10 mg/Simvastatin 20 mg · Logistic Regression using GEE · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 3.05 · 95% CI 2.04 to 4.55Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
  • Ezetimibe 10 mg/Simvastatin 20 mg vs Atorvastatin 20 mg · Logistic Regression using GEE · p = 0.039 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 1.54 · 95% CI 1.02 to 2.32Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
  • Ezetimibe 10 mg/Simvastatin 40 mg vs Atorva 40 mg · Logistic Regression using GEE · p = 0.023 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 1.81 · 95% CI 1.14 to 2.87Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
SecondaryPercentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12
Time frame:
12 Weeks
Reported as:
Mean · Percent of Patients
Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12
Percent of PatientsAtorvastatin 10 mgEzetimibe 10 mg/Simvastatin 20 mgAtorvastatin 20 mgEzetimibe 10 mg/Simvastatin 40 mgAtorva 40 mg
Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 1258.7 ± 3.1783.6 ± 2.4376.9 ± 2.7390.3 ± 1.9379.5 ± 2.61
Statistical analysis
  • Atorvastatin 10 mg vs Ezetimibe 10 mg/Simvastatin 20 mg · Logistic Regression using GEE · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 4.47 · 95% CI 2.76 to 7.24Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
  • Ezetimibe 10 mg/Simvastatin 20 mg vs Atorvastatin 20 mg · Logistic Regression using GEE · p = 0.026 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 1.77 · 95% CI 1.07 to 2.94Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
  • Ezetimibe 10 mg/Simvastatin 40 mg vs Atorva 40 mg · Logistic Regression using GEE · p = 0.017 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 2.27 · 95% CI 1.23 to 4.18Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
SecondaryPercentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12

Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.

Time frame:
12 Weeks
Reported as:
Mean · Percent of Patients
Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12
Percent of PatientsAtorvastatin 10 mgEzetimibe 10 mg/Simvastatin 20 mgAtorvastatin 20 mgEzetimibe 10 mg/Simvastatin 40 mgAtorva 40 mg
Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 1210.9 ± 2.6554.3 ± 4.2428.9 ± 4.0169.2 ± 4.0538.2 ± 4.17
Statistical analysis
  • Atorvastatin 10 mg vs Ezetimibe 10 mg/Simvastatin 20 mg · Logistic Regression using GEE · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 7.60 · 95% CI 4.31 to 13.42Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
  • Ezetimibe 10 mg/Simvastatin 20 mg vs Atorvastatin 20 mg · Logistic Regression using GEE · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 2.95 · 95% CI 1.86 to 4.67Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
  • Ezetimibe 10 mg/Simvastatin 40 mg vs Atorva 40 mg · Logistic Regression using GEE · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 2.15 · 95% CI 1.42 to 3.27Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
SecondaryPercentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12

Patients with AVD Who Achieved LDL-C \<70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.

Time frame:
12 Weeks
Reported as:
Mean · Percent of Patients
Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12
Percent of PatientsAtorvastatin 10 mgEzetimibe 10 mg/Simvastatin 20 mgAtorvastatin 20 mgEzetimibe 10 mg/Simvastatin 40 mgAtorva 40 mg
Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 1210.0 ± 3.5944.4 ± 5.5231.6 ± 5.2365.8 ± 5.3444.4 ± 5.86
Statistical analysis
  • Atorvastatin 10 mg vs Ezetimibe 10 mg/Simvastatin 20 mg · Logistic Regression using GEE · p = <0.001 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 6.02 · 95% CI 2.71 to 13.38Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
  • Ezetimibe 10 mg/Simvastatin 20 mg vs Atorvastatin 20 mg · Logistic Regression using GEE · p = 0.069 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 1.67 · 95% CI 0.96 to 2.60Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva
  • Ezetimibe 10 mg/Simvastatin 40 mg vs Atorva 40 mg · Logistic Regression using GEE · p = 0.039 (Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.) · Ratio of odds: 1.78 · 95% CI 1.10 to 2.90Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Atorvastatin 10 mg—4/257 (1.6%)26/257 (10.1%)
Ezetimibe 10 mg/Simvastatin 20 mg—8/256 (3.1%)32/256 (12.5%)
Atorvastatin 20 mg—3/258 (1.2%)26/258 (10.1%)
Ezetimibe 10 mg/Simvastatin 40 mg—3/257 (1.2%)32/257 (12.5%)
Atorvastatin 40 mg—5/256 (2%)30/256 (11.7%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventAtorvastatin 10 mgEzetimibe 10 mg/Simvastatin 20 mgAtorvastatin 20 mgEzetimibe 10 mg/Simvastatin 40 mgAtorvastatin 40 mg
Acute myocardial infarctionCardiac disorders1/2572/2560/2580/2570/256
Myocardial infarctionCardiac disorders0/2570/2560/2582/2570/256
AV dissociationCardiac disorders0/2571/2560/2580/2570/256
Abdominal painGastrointestinal disorders0/2570/2560/2580/2571/256
Colitis ischaemicGastrointestinal disorders0/2571/2560/2580/2570/256
Diverticulum intestinalGastrointestinal disorders0/2571/2560/2580/2570/256
Gastrointestinal haemorrhageGastrointestinal disorders0/2571/2560/2580/2570/256
Oedema peripheralGeneral disorders0/2570/2560/2580/2571/256
Urinary tract infectionInfections and infestations0/2570/2560/2580/2571/256
Femur fractureInjury, poisoning and procedural complications0/2570/2560/2580/2571/256
Most frequent other events
Showing 10 of 13
Most frequent other events
EventAtorvastatin 10 mgEzetimibe 10 mg/Simvastatin 20 mgAtorvastatin 20 mgEzetimibe 10 mg/Simvastatin 40 mgAtorvastatin 40 mg
DizzinessNervous system disorders2/2576/2560/2582/2573/256
ConstipationGastrointestinal disorders3/2570/2560/2584/2575/256
NasopharyngitisInfections and infestations2/2575/2564/2583/2572/256
HeadacheNervous system disorders1/2575/2563/2583/2572/256
Back painMusculoskeletal and connective tissue disorders5/2572/2563/2584/2574/256
MyalgiaMusculoskeletal and connective tissue disorders5/2573/2563/2582/2573/256
BronchitisInfections and infestations1/2572/2564/2584/2574/256
Muscle spasmsMusculoskeletal and connective tissue disorders1/2574/2564/2581/2571/256
DiarrhoeaGastrointestinal disorders3/2571/2561/2584/2573/256
Aspartate aminotransferase increasedInvestigations0/2572/2560/2584/2573/256

Baseline characteristics

Age, Continuous
Age, Continuous(years)Atorvastatin 10 mgEzetimibe 10 mg/Simvastatin 20 mgAtorvastatin 20 mgEzetimibe 10 mg/Simvastatin 40 mgAtorva 40 mgTotal
Mean72.1 (65 to 94)71.8 (65 to 95)71.7 (65 to 90)72.2 (65 to 96)72.1 (65 to 88)72.0 (65 to 96)
Sex: Female, Male
Sex: Female, Male(Participants)Atorvastatin 10 mgEzetimibe 10 mg/Simvastatin 20 mgAtorvastatin 20 mgEzetimibe 10 mg/Simvastatin 40 mgAtorva 40 mgTotal
Female172146175153163809
Male851138410494480
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Atorvastatin 10 mgEzetimibe 10 mg/Simvastatin 20 mgAtorvastatin 20 mgEzetimibe 10 mg/Simvastatin 40 mgAtorva 40 mgTotal
Asian1061281046
Black2286927
Other2127302928135
White2242242092142101081
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Foody JM, Brown WV, Zieve F, Adewale AJ, Flaim D, Lowe RS, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults >/=65 years of age with hypercholesterolemia and with or at moderately high/high risk for coronary heart disease (the VYTELD study). Am J Cardiol. 2010 Nov 1;106(9):1255-63. doi: 10.1016/j.amjcard.2010.06.051. PubMed 21029821 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00535405
Lead sponsor
Organon and Co
Collaborators
Merck Shering-Plough JV Study
Responsible party
Sponsor
First posted
Sep 26, 2007
Start date
Nov 2007
Primary completion
Mar 2009
Completion
Mar 2009
Results posted
May 25, 2010
Last update
May 16, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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