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NCT00132717 Clinical Trial

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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00132717
Other study ID # 0653A-808
Secondary ID 2004_046
Status Completed
Phase Phase 3
First received
Last updated
Start date January 1, 2005
Est. completion date June 1, 2007

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date June 1, 2007
Est. primary completion date June 1, 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0653A (ezetimibe [+] simvastatin)

• Comparator: atorvastatin

• Comparator: fluvastatin

• Comparator: lovastatin

• Comparator: pravastatin

• Comparator: rosuvastatin

• Comparator: simvastatin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (2)

Brudi 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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To determine the effect of MK0653A compared to doubling the statin dose on total cholesterol (TC) after 12 weeks After 12 weeks of treatment
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