A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

Hypercholesterolemia Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Parallel, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Elderly Patients With Hypercholesterolemia at High or Moderately High Risk for Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535405
• Other study ID #: 0653A-128
• Secondary ID: 2007_588
• Status: Completed
• Phase: Phase 3
• Start date: November 2007
• Est. completion date: March 2009

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1289
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patient has a cholesterol level of 130 mg/dL or greater

• Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study

• Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines

Exclusion Criteria:

• Patient weighs less than 100 lbs

• Patient has an allergy to ezetimibe, simvastatin or atorvastatin

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hypercholesterolemia
• Myocardial Ischemia

Intervention

Drug:
• Atorvastatin 10 mg
Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
• Ezetimibe 10 mg/simvastatin 20 mg
Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks
• Atorvastatin 20 mg
Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks
• Ezetimibe 10 mg/simvastatin 40 mg
Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks
• Atorvastatin 40 mg
Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Organon and Co	Merck Shering-Plough JV Study

References & Publications (1)

Foody JM, Brown WV, Zieve F, Adewale AJ, Flaim D, Lowe RS, Jones-Burton C, Tershakovec AM. Safety and efficacy of ezetimibe/simvastatin combination versus atorvastatin alone in adults >/=65 years of age with hypercholesterolemia and with or at moderately — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12		Baseline and 12 weeks
Secondary	Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12		12 weeks
Secondary	Percentage of Patients Without Atherosclerosis Vascular Disease (AVD) Who Achieved LDL-C <100 mg/dL or Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12	Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.	12 Weeks
Secondary	Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12		12 Weeks
Secondary	Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12	Risk was assessed utilizing a history of established CHD or CHD risk equivalent and Framingham Risk scoring.	12 Weeks
Secondary	Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12	Patients with AVD Who Achieved LDL-C <70 mg/dL. AVD was defined as a history of myocardial infarction, stable angina, coronary artery procedures or evidence of clinically significant myocardial ischemia.	12 Weeks