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)

NCT ID: NCT00535405

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1289 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-03-31

Brief 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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Each patient will receive 1 active treatment dose \& 2 Placebo (Pbo) doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

Group Type: EXPERIMENTAL

Atorvastatin 10 mg

Intervention Type: DRUG

Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

2

Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

Group Type: EXPERIMENTAL

Ezetimibe 10 mg/simvastatin 20 mg

Intervention Type: DRUG

Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks

3

Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

Group Type: EXPERIMENTAL

Atorvastatin 20 mg

Intervention Type: DRUG

Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

4

Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

Group Type: EXPERIMENTAL

Ezetimibe 10 mg/simvastatin 40 mg

Intervention Type: DRUG

Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks

5

Each patient will receive 1 active treatment dose \& 2 Pbo doses or 2 active treatment doses \& 1 Pbo dose at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 12 weeks.

Group Type: EXPERIMENTAL

Atorvastatin 40 mg

Intervention Type: DRUG

Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Interventions

Atorvastatin 10 mg

Atorvastatin 10 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Intervention Type: DRUG

Ezetimibe 10 mg/simvastatin 20 mg

Ezetimibe 10 mg/simvastatin 20 mg and Placebo for atorvastatin once daily for 12 weeks

Intervention Type: DRUG

Atorvastatin 20 mg

Atorvastatin 20 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Intervention Type: DRUG

Ezetimibe 10 mg/simvastatin 40 mg

Ezetimibe 10 mg/simvastatin 40 mg and Placebo for atorvastatin once daily for 12 weeks

Intervention Type: DRUG

Atorvastatin 40 mg

Atorvastatin 40 mg and Placebo for ezetimibe and placebo for simvastatin once daily for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Shering-Plough JV Study

UNKNOWN

Sponsor Role: collaborator

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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 high/high risk for coronary heart disease (the VYTELD study). Am J Cardiol. 2010 Nov 1;106(9):1255-63. doi: 10.1016/j.amjcard.2010.06.051.

Reference Type: RESULT

PMID: 21029821 (View on PubMed)

Other Identifiers

2007_588

Identifier Type: -

Identifier Source: secondary_id

0653A-128

Identifier Type: -

Identifier Source: org_study_id