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CompletedNCT00442897Updated May 22, 2024Results posted

Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)

A Phase 4 interventional study of simvastatin (+) ezetimibe and Comparator: atorvastatin in Hypercholesterolemia, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-22.

Sponsored by Organon and Co · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
229
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines

02

Conditions studied

  • Hypercholesterolemia

Keywords

  • Hypercholesterolaemia
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 229 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease 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
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who are naïve to lowering lipid agent
  • Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks.

Exclusion criteria

Exclusion Criteria:

  • Impaired kidney function
  • Increased liver enzyme levels
  • Pregnant women
  • Hypersensitivity to ezetimibe and other statin agents
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
229 participants (actual)

Study arms

  • Experimental
    1

    Drug: simvastatin (+) ezetimibe

  • Active comparator
    2

    Drug: Comparator: atorvastatin

Interventions

  • Drugsimvastatin (+) ezetimibe

    simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks)

    Also known as: MK0653A, Vytorin®

  • DrugComparator: atorvastatin

    atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)

    Also known as: Lipitor®

06

What researchers measure

Primary outcomes

  1. Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment

    Primary objective is to evaluate the proportion of patients achieving LDL-C target \<100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)

    Time frame: After 6 weeks of treatment

Secondary outcomes

  1. Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment

    If patients didn't achieve LDL-C \<100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks.

    Time frame: After 12 weeks of the treatment

07

Results

Posted Nov 9, 2009

Participant flow

Patient were recruited between September 2006 and May 2008.

Base Study (12 Week Follow-up)
Participant flow — Base Study (12 Week Follow-up)
MilestoneVytorinAtorvastatin
Started118111
Completed10199
Not completed1712
Withdrew: Adverse event10
Withdrew: Death01
Withdrew: Protocol violation73
Withdrew: Withdrawal by subject98
24 Weeks Follow-up (3 Centers)
Participant flow — 24 Weeks Follow-up (3 Centers)
MilestoneVytorinAtorvastatin
Started3534
Completed2928
Not completed66
Withdrew: Adverse event10
Withdrew: Lost to follow-up22
Withdrew: Protocol violation21
Withdrew: Withdrawal by subject13

Outcome measures

PrimaryNumber of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment

Primary objective is to evaluate the proportion of patients achieving LDL-C target \<100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg)

Time frame:
After 6 weeks of treatment
Reported as:
Number · Participants
Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment
ParticipantsVytorinAtorvastatin
Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment8963
Statistical analysis
  • Vytorin vs Atorvastatin · Odds ratio (or): 3.714 · 95% CI 1.77 to 7.78Odds ratio was adjusted by baseline LDL strata.
SecondaryNumber of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment

If patients didn't achieve LDL-C \<100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C \< 100 mg/dl, they received the same dosage of study drug for the next 6 weeks.

Time frame:
After 12 weeks of the treatment
Reported as:
Number · Participants
Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment
ParticipantsVytorinAtorvastatin
Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment8563
Statistical analysis
  • Vytorin vs Atorvastatin · Odds ratio (or): 2.579 · 95% CI 1.32 to 5.06Odds ratio was adjusted by baseline LDL strata.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vytorin—0/108 (0%)19/108 (17.6%)
Atorvastatin—5/103 (4.9%)22/103 (21.4%)
Most frequent serious events
Most frequent serious events
EventVytorinAtorvastatin
Acute myocardial infarctionCardiac disorders0/1083/103
Cardiogenic shockCardiac disorders0/1081/103
Ventricular tachycardiaCardiac disorders0/1081/103
Gastrointestinal haemorrhageGastrointestinal disorders0/1081/103
CholelithiasisHepatobiliary disorders0/1081/103
Thrombosis in deviceInjury, poisoning and procedural complications0/1081/103
ArthralgiaMusculoskeletal and connective tissue disorders0/1081/103
CoughRespiratory, thoracic and mediastinal disorders0/1081/103
Most frequent other events
Showing 10 of 39
Most frequent other events
EventVytorinAtorvastatin
Upper respiratory tract infectionInfections and infestations4/1080/103
NasopharyngitisInfections and infestations1/1082/103
Generalized oedemaGeneral disorders0/1082/103
MyalgiaMusculoskeletal and connective tissue disorders0/1082/103
Pain in extremityMusculoskeletal and connective tissue disorders0/1082/103
Blood creatine phosphokinase increasedInvestigations1/1082/103
HeadacheInfections and infestations2/1081/103
Transaminases increasedInvestigations2/1080/103
CystitisInfections and infestations0/1081/103
DysphasiaNervous system disorders0/1081/103

Baseline characteristics

Age, Continuous
Age, Continuous(years)VytorinAtorvastatinTotal
Mean60.89 ± 9.2861.74 ± 9.9461.30 ± 9.59
Sex: Female, Male
Sex: Female, Male(Participants)VytorinAtorvastatinTotal
Female5753110
Male6158119
Baseline Low Density Lipoprotein-Cholesterol (LDL-C) allocation strata
Baseline Low Density Lipoprotein-Cholesterol (LDL-C) allocation strata(Participants)VytorinAtorvastatinTotal
LDL-C 130-159mg/dl6461125
LDL-C 160-189mg/dl383169
LDL-C >=190mg/dl161834
LDL-C <130mg/dl011
Baseline values for Apolipoprotein B (Apo B)
Baseline values for Apolipoprotein B (Apo B)(mg/dL)VytorinAtorvastatinTotal
Mean113.23 ± 30.97110.63 ± 31.63111.97 ± 31.25
Baseline values for High-Density Lipoprotein Cholesterol (HDL-C)
Baseline values for High-Density Lipoprotein Cholesterol (HDL-C)(mg/dL)VytorinAtorvastatinTotal
Mean48.23 ± 10.2548.9 ± 13.0148.55 ± 11.65
Baseline values for LDL-C:HDL-C
Baseline values for LDL-C:HDL-C(Ratio)VytorinAtorvastatinTotal
Mean3.54 ± 1.133.54 ± 1.043.54 ± 1.08
Baseline values for Low-Density Lipoprotein Cholesterol(LDL-C)
Baseline values for Low-Density Lipoprotein Cholesterol(LDL-C)(mg/dL)VytorinAtorvastatinTotal
Mean164.11 ± 33.52162.56 ± 26.75163.36 ± 30.37
Baseline values for Non HDL-C
Baseline values for Non HDL-C(mg/dL)VytorinAtorvastatinTotal
Mean191.54 ± 38.25190.72 ± 31.11191.14 ± 34.88

6 further baseline measures are reported on the registry.

08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00442897
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Mar 5, 2007
Start date
Sep 2006
Primary completion
Oct 2008
Completion
Oct 2008
Results posted
Nov 9, 2009
Last update
May 22, 2024

Study contacts

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

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