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CompletedNCT00092690Updated May 10, 2024

MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)

A Phase 3 interventional study of MK0653A, ezetimibe (+) simvastatin and Comparator: atorvastatin in Hypercholesterolemia, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-05-10.

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

Phase
Phase 3
Study type
Interventional
Enrollment
1,902
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

This study is to assess the safety and efficacy of an investigational drug as compared to an approved drug to reduce specific cholesterol levels.

Read the detailed description

The duration of treatment is 6 weeks.

02

Conditions studied

  • Hypercholesterolemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 1,902 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia 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 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Elevated cholesterol

Exclusion criteria

Exclusion Criteria:

  • Unstable medical conditions or significant heart problems within 3 months prior to first study visit.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,902 participants (actual)

Interventions

  • DrugMK0653A, ezetimibe (+) simvastatin
  • DrugComparator: atorvastatin
06

What researchers measure

Primary outcomes

  1. Plasma LDL-C averaged across all doses after 6 weeks

Secondary outcomes

  1. Plasma LDL-C for each dose; plasma HDL-C averaged across all doses

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Ballantyne CM, Abate N, Yuan Z, King TR, Palmisano J. Dose-comparison study of the combination of ezetimibe and simvastatin (Vytorin) versus atorvastatin in patients with hypercholesterolemia: the Vytorin Versus Atorvastatin (VYVA) study. Am Heart J. 2005 Mar;149(3):464-73. doi: 10.1016/j.ahj.2004.11.023. Erratum In: Am Heart J. 2005 May;149(5):882. PubMed 15864235 ↗
  • Pearson T, Ballantyne C, Sisk C, Shah A, Veltri E, Maccubbin D. Comparison of effects of ezetimibe/simvastatin versus simvastatin versus atorvastatin in reducing C-reactive protein and low-density lipoprotein cholesterol levels. Am J Cardiol. 2007 Jun 15;99(12):1706-1713. doi: 10.1016/j.amjcard.2007.01.062. Epub 2007 May 2. PubMed 17560879 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00092690
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Sep 28, 2004
Start date
Jun 2003
Primary completion
Mar 2004
Completion
Mar 2004
Last update
May 10, 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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