Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-803)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00092625
• Collaborator: (none)
• Enrollment: 442
• Duration (Months): 17.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia; Coronary Disease	Drug: MK0653, ezetimibe; Drug: Comparator: ezetimibe, placebo	Phase 3

Detailed Description

The duration of treatment is 10 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 442 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Added to Existing Atorvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.
• Study Start Date: Mar 1, 2003
• Actual Primary Completion Date: Jul 1, 2004
• Actual Study Completion Date: Aug 1, 2004

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Safety and tolerability. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cruz-Fernández JM, Bedarida GV, Adgey J, Allen C, Johnson-Levonas AO, Massaad R. Efficacy and safety of ezetimibe co-administered with ongoing atorvastatin therapy in achieving low-density lipoprotein goal in patients with hypercholesterolemia and coronary heart disease. Int J Clin Pract. 2005 Jun;59(6):619-27.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00092625
• Other Study ID Numbers: 0653-803; 2004_041
• First Posted: Sep 27, 2004
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Organon and Co: Elevated Cholesterol
• Additional relevant MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia; Ezetimibe

Study Results

No Results Posted as of Feb 15, 2022