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CompletedNCT00551447Updated Aug 15, 2024

A Study Comparing Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Patients at Risk for Heart Disease (0653-023)(COMPLETED)

A Phase 3 interventional study of MK0653, ezetimibe / Duration of Treatment: 27 Weeks and MK0733, simvastatin / Duration of Treatment: 27 Weeks in Coronary Disease, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-15.

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

Phase
Phase 3
Study type
Interventional
Enrollment
616
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This purpose of this study is to determine if the administration of ezetimibe and simvastatin together is more effective than simvastatin alone in lowering LDL-C levels to a goal of \<100 mg/dL in patients at risk for Heart Disease.

02

Conditions studied

  • Coronary Disease

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03

In context

Coronary Disease

2,867 studies on the registry are indexed under Coronary Disease; 309 are open to participants now.

This study's enrollment of 616 is above the median of 124 across 1,601 interventional studies indexed under Coronary Disease.

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Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

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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

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Inclusion criteria

  • Men and women aged 18 to 80 at risk for Heart Disease who have LDL-C levels greater than or equal to 130 mg/dL and triglyceride level less than or equal to 350 mg/dL
  • Patients must be able to maintain the National Cholesterol Education Program diet throughout the course of the study

Exclusion criteria

Exclusion Criteria:

  • Patients are excluded from the study if their weight is less than 50% of ideal body weight, if they are pregnant or lactating, have congestive heart failure, uncontrolled heart rhythm problems or a recent heart attack, coronary artery bypass surgery, or angioplasty. Additionally, patients with poorly controlled Type 1 or 2 diabetes mellitus, kidney disease, uncontrolled endocrine or metabolic disease, are known HIV positive, and uncontrolled high blood pressure
05

Study design

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

Interventions

  • DrugMK0653, ezetimibe / Duration of Treatment: 27 Weeks
  • DrugMK0733, simvastatin / Duration of Treatment: 27 Weeks
  • DrugComparator: simvastatin / Duration of Treatment: 27 Weeks
06

What researchers measure

Primary outcomes

  1. LDL-C measurement (target goal = <100 mg/dL)

    Time frame: 27 Weeks

Secondary outcomes

  1. Well tolerated in patients

    Time frame: 27 Weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • McKenney J, Ballantyne CM, Feldman TA, Brady WE, Shah A, Davies MJ, Palmisano J, Mitchel YB. LDL-C goal attainment with ezetimibe plus simvastatin coadministration vs atorvastatin or simvastatin monotherapy in patients at high risk of CHD. MedGenMed. 2005 Jul 14;7(3):3. PubMed 16369229 ↗
  • Feldman T, Koren M, Insull W Jr, McKenney J, Schrott H, Lewin A, Shah S, Sidisin M, Cho M, Kush D, Mitchel Y. Treatment of high-risk patients with ezetimibe plus simvastatin co-administration versus simvastatin alone to attain National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol goals. Am J Cardiol. 2004 Jun 15;93(12):1481-6. doi: 10.1016/j.amjcard.2004.02.059. PubMed 15194017 ↗
  • Catapano A, Brady WE, King TR, Palmisano J. Lipid altering-efficacy of ezetimibe co-administered with simvastatin compared with rosuvastatin: a meta-analysis of pooled data from 14 clinical trials. Curr Med Res Opin. 2005 Jul;21(7):1123-30. doi: 10.1185/030079905X50642. PubMed 16004682 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2002, a primary completion of Mar 2003 and a completion of Mar 2003. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2007
First posted
Oct 31, 2007
Start
Jan 2002
Primary completionActual
Mar 2003
CompletionActual
Mar 2003
Last update
Aug 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00551447
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Oct 31, 2007
Start date
Jan 2002
Primary completion
Mar 2003
Completion
Mar 2003
Last update
Aug 15, 2024

Study contacts

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

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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