A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)
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
2 other identifiers
interventional
450
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 2, 2005
CompletedFirst Posted
Study publicly available on registry
August 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedAugust 15, 2024
February 1, 2022
2.4 years
August 2, 2005
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (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
After 12 weeks of treatment
Secondary Outcomes (1)
To determine the effect of MK0653A compared to doubling the statin dose on total cholesterol (TC) after 12 weeks
After 12 weeks of treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who have congestive heart failure (CHF), uncontrolled high blood pressure, poorly controlled blood sugar, impaired kidney function, or HIV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (2)
Reckless JP, Henry P, Pomykaj T, Lim ST, Massaad R, Vandormael K, Johnson-Levonas AO, Lis K, Brudi P, Allen C. Lipid-altering efficacy of ezetimibe/simvastatin 10/40 mg compared with doubling the statin dose in patients admitted to the hospital for a recent coronary event: the INFORCE study. Int J Clin Pract. 2008 Apr;62(4):539-54. doi: 10.1111/j.1742-1241.2008.01697.x. Epub 2008 Feb 11.
PMID: 18266852BACKGROUNDBrudi P, Reckless JP, Henry DP, Pomykaj T, Lim ST, Massaad R, Vandormael K, Johnson-Levonas AO. Efficacy of ezetimibe/simvastatin 10/40 mg compared to doubling the dose of low-, medium- and high-potency statin monotherapy in patients with a recent coronary event. Cardiology. 2009;113(2):89-97. doi: 10.1159/000172795. Epub 2008 Nov 15.
PMID: 19018143BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2005
First Posted
August 22, 2005
Study Start
January 1, 2005
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
August 15, 2024
Record last verified: 2022-02