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)

NCT00535405 | Completed Phase 3 Results

• 2 other identifiers: 0653A-1282007_588
• Study Type: interventional
• Target: 1,289
• Locations: 0 countries
• Sites: N/A

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

Keywords

High Cholesterol

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12

  Baseline and 12 weeks

Secondary Outcomes (5)

• Percentage of Patients Who Achieved LDL-C <70 mg/dL at Week 12

  12 weeks

• 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

  12 Weeks

• Percentage of Patients Who Achieved LDL-C <100 mg/dL at Week 12

  12 Weeks

• Percentage of Patients With High Risk for CHD Who Achieved LDL-C <70 mg/dL at Week 12

  12 Weeks

• Percentage of Patients With AVD Who Achieved LDL-C <70 mg/dL at Week 12

  12 Weeks

Study Arms (5)

1

EXPERIMENTAL

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.

Drug: Atorvastatin 10 mg

2

EXPERIMENTAL

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.

Drug: Ezetimibe 10 mg/simvastatin 20 mg

3

EXPERIMENTAL

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.

Drug: Atorvastatin 20 mg

4

EXPERIMENTAL

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.

Drug: Ezetimibe 10 mg/simvastatin 40 mg

5

EXPERIMENTAL

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.

Drug: Atorvastatin 40 mg

Interventions

Atorvastatin 10 mg DRUG

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

1

Ezetimibe 10 mg/simvastatin 20 mg DRUG

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

2

Atorvastatin 20 mg DRUG

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

3

Ezetimibe 10 mg/simvastatin 40 mg DRUG

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

4

Atorvastatin 40 mg DRUG

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

5

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient weighs less than 100 lbs
• Patient has an allergy to ezetimibe, simvastatin or atorvastatin

Sponsors & Collaborators

• Organon and Co: lead
• Merck Shering-Plough JV Study: collaborator

Related 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 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.

  PMID: 21029821 RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Atorvastatin; Ezetimibe; Simvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Azetidines; Azetines; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2007
• First Posted: September 26, 2007
• Study Start: November 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 16, 2024
• Results First Posted: May 25, 2010

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share