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A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)

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ClinicalTrials.gov Identifier: NCT00132717
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : February 16, 2022
Information provided by (Responsible Party):
Organon and Co

Brief Summary:
The purpose of this study is to investigate the effect of an investigational cholesterol-lowering drug in patients who are currently taking an approved medication for hypercholesterolemia (high cholesterol levels) and have been hospitalized for a heart problem.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: MK0653A (ezetimibe [+] simvastatin) Drug: Comparator: atorvastatin Drug: Comparator: fluvastatin Drug: Comparator: lovastatin Drug: Comparator: pravastatin Drug: Comparator: rosuvastatin Drug: Comparator: simvastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study to Assess the Efficacy of Switching to a Combination Tablet Ezetimibe/Simvastatin 10mg/40mg, Compared to Doubling the Dose of Statin in Patients Hospitalized With a Coronary Event
Actual Study Start Date : January 1, 2005
Actual Primary Completion Date : June 1, 2007
Actual Study Completion Date : June 1, 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Evaluate the effectiveness of MK0653A compared to doubling the statin dose as shown by the low-density lipoprotein cholesterol (LDL-C) values achieved after 12 weeks of treatment [ Time Frame: After 12 weeks of treatment ]

Secondary Outcome Measures :
  1. To determine the effect of MK0653A compared to doubling the statin dose on total cholesterol (TC) after 12 weeks [ Time Frame: After 12 weeks of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients greater than 18 years old, who were admitted to a hospital for an investigation of a heart problem and are currently receiving an approved medication to lower cholesterol

Exclusion Criteria:

  • Patients who have congestive heart failure (CHF), uncontrolled high blood pressure, poorly controlled blood sugar, impaired kidney function, or HIV.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132717

Sponsors and Collaborators
Organon and Co
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00132717    
Other Study ID Numbers: 0653A-808
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: February 16, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
L 647318
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors