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...
Date First Received: August 2, 2005
Last Updated: September 8, 2008
Verified by: Merck, September 2008
Clinical Trial Phase: Phase 3 | Start Date: January 2005
Overall Status: Completed
Estimated Enrollment: 450
Brief Summary
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”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: MK0653A (ezetimibe [+] simvastatin)
- Drug: Comparator: atorvastatin
- Drug: Comparator: fluvastatin
- Drug: Comparator: lovastatin
- Drug: Comparator: pravastatin
- Drug: Comparator: rosuvastatin
- Drug: Comparator: simvastatin
Outcome Measures for this Clinical Trial
Primary Measures
- 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
Safety Issue?: No
- Time Frame: After 12 weeks of treatment
Secondary Measures
- 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
Safety Issue?: No
- Time Frame: After 12 weeks of treatment
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
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. Epub 2008 Feb 11.
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00132717
Study ID Number: 2004_046
ClinicalTrials.gov Identifier: NCT00132717
Health Authority: France: Afssaps - French Health Products Safety Agency
Clinical Trials Authorship and Review
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