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CompletedNCT00092612Updated Aug 15, 2024

Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED)

A Phase 3 interventional study of MK0653, ezetimibe and Comparator: ezetimibe, placebo in Hypercholesterolemia and Coronary Disease, sponsored by Organon and Co. Completed. Open to participants aged 18 Years and older. 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
372
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

Read the detailed description

The duration of treatment is 10 weeks.

02

Conditions studied

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 372 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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with elevated cholesterol and coronary heart disease

Exclusion criteria

Exclusion Criteria:

  • Patients who have cholesterol levels within normal ranges as identified by the study
05

Study design

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

Interventions

  • DrugMK0653, ezetimibe
  • DrugComparator: ezetimibe, placebo
06

What researchers measure

Primary outcomes

  1. Percentage of patients reaching their target LDL-C goal of </= 2.60 mmol/L, after 6 weeks of treatment

Secondary outcomes

  1. Safety and tolerability.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Farnier M, Volpe M, Massaad R, Davies MJ, Allen C. Effect of co-administering ezetimibe with on-going simvastatin treatment on LDL-C goal attainment in hypercholesterolemic patients with coronary heart disease. Int J Cardiol. 2005 Jul 10;102(2):327-32. doi: 10.1016/j.ijcard.2005.01.022. PubMed 15982505 ↗
09

Updates

Tracking since Sep 25, 2026
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
NCT00092612
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Sep 27, 2004
Start date
May 2003
Primary completion
Jun 2004
Completion
Jun 2004
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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