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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00132717
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00132717    
Other Study ID Numbers: 0653A-808
2004_046
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin Calcium
Simvastatin
Ezetimibe
Pravastatin
Lovastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors