Trial Outcomes & Findings for Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL) (NCT NCT00932620)

NCT ID: NCT00932620

Last Updated: 2011-08-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: Baseline and 3 months
• Results posted on: 2011-08-19

Participant Flow

Participant milestones

Measure	Simvastatin 40 mg All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily	Simvastatin 10 mg Plus Ezetimibe 10 mg All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL)

Baseline characteristics by cohort

Measure	Simvastatin 40 mg n=50 Participants All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily	Simvastatin 10 mg Plus Ezetimibe 10 mg n=50 Participants All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	44 Participants n=7 Participants	89 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Age Continuous	57 years STANDARD_DEVIATION 10 • n=5 Participants	59 years STANDARD_DEVIATION 9 • n=7 Participants	58 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment Greece	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Outcome measures

Measure	Simvastatin 40 mg n=50 Participants All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily	Simvastatin 10 mg Plus Ezetimibe 10 mg n=50 Participants All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
Changes in Small Dense Low-density Lipoprotein Cholesterol (sdLDL-C) Levels	-42 sdLDL-C, mg/dL Standard Deviation 10	-46 sdLDL-C, mg/dL Standard Deviation 13

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	Simvastatin 40 mg n=50 Participants All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily	Simvastatin 10 mg Plus Ezetimibe 10 mg n=50 Participants All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
Changes in Low-density Lipoprotein Cholesterol (LDL-C)	-43 LDL-C, mg/dL Standard Deviation 10	-49 LDL-C, mg/dL Standard Deviation 12

Adverse Events

Simvastatin 40 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Simvastatin 10 mg Plus Ezetimibe 10 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof Moses Elisaf

University of Ioannina

Phone: +302651007509

Email: egepi@cc.uoi.gr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place