A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)

Hypercholesterolemia Clinical Trial

Official title:

A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary High Cholesterol and High Cardiovascular Risk Not Controlled With a Prior Statin Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479713
• Other study ID #: 0653A-809
• Secondary ID: 2007_552
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2007
• Est. completion date: March 1, 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 618
• Est. completion date: March 1, 2008
• Est. primary completion date: March 1, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Participant is currently taking a statin medication for the treatment of high cholesterol

• Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl

Exclusion Criteria:

• Women who are pregnant or nursing, or women who intend to become pregnant

• Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.
• Comparator : rosuvastatin calcium
rosuvastatin 10mg. The treatment duration will be 6 weeks.
• Comparator: Placebo (unspecified)
rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.
• Comparator: Placebo (unspecified)
ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Farnier M, Averna M, Missault L, Vaverkova H, Viigimaa M, Massaad R, Vandormael K, Johnson-Levonas AO, Brudi P. Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study. Int J Clin Pract. 2009 Apr;63(4):547-59. doi: 10.1111/j.1742-1241.2009.02022.x. Epub 2009 Feb 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent Change From Baseline in Total Cholesterol	Percent change from baseline in total cholesterol at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.	Baseline and 6 weeks
Other	Percent Change From Baseline in Triglycerides.	Percent change from baseline in triglycerides at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.	Baseline and 6 weeks
Other	Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)	Percent change from baseline in HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.	Baseline and 6 weeks
Other	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C)	Percent change from baseline in non HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.	Baseline and 6 weeks
Other	Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio	Percent change from baseline in LDL-C/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.	Baseline and 6 weeks
Other	Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio	Percent change from baseline in total cholesterol/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.	Baseline and 6 weeks
Other	Percent Change From Baseline in Apolipoprotein B	Percent change from baseline in apolipoprotein (Apo) B at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.	Baseline and 6 weeks
Other	Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein	Percent change from baseline in hs-C reactive protein at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.	Baseline and 6 weeks
Primary	Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment	Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.	Baseline and 6 weeks
Secondary	The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment	The percentage of participants who achieved a target LDL-C goal of < 100 mg/dL, of <70 mg/dL, and of <77 mg/dL at study endpoint after six weeks of treatment.; The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group.	after 6 weeks of treatment