Trial Outcomes & Findings for Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe) (NCT NCT00762229)

NCT ID: NCT00762229

Last Updated: 2013-06-14

Results Overview

LDL cholesterol

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2013-06-14

Participant Flow

Patients were recruited from themedical, cardiology and lipid clinics from Spetember 2007 through April 2008.

The drug was prescribed once daily. No patients were excluded after randomization

Participant milestones

Measure	Ezetimibe 10 mg A whole ezetimibe 10 mg tablet	Ezetimibe 5 mg Ezetimibe 5 mg,
Overall Study STARTED	15	24
Overall Study COMPLETED	14	22
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Ezetimibe 10 mg A whole ezetimibe 10 mg tablet	Ezetimibe 5 mg Ezetimibe 5 mg,
Overall Study Lost to Follow-up	1	1
Overall Study did not recveive intervention	0	1

Baseline Characteristics

Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe)

Baseline characteristics by cohort

Measure	Ezetimibe 10 mg n=15 Participants A whole ezetimibe 10 mg tablet	Ezetimibe 5 mg n=24 Participants Ezetimibe 5 mg,	Total n=39 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	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants
Age Continuous	69 years STANDARD_DEVIATION 9.2 • n=5 Participants	72 years STANDARD_DEVIATION 10.1 • n=7 Participants	70.5 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	23 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	24 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

LDL cholesterol

Outcome measures

Measure	Ezetimibe 10 mg n=14 Participants A whole ezetimibe 10 mg tablet	Ezetimibe 5 mg n=22 Participants Ezetimibe 5 mg,
LDL Cholesterol	103 mg/dL Standard Deviation 24	97 mg/dL Standard Deviation 38

SECONDARY outcome

Timeframe: 4 weeks

Total cholesterol fasting

Outcome measures

Measure	Ezetimibe 10 mg n=14 Participants A whole ezetimibe 10 mg tablet	Ezetimibe 5 mg n=22 Participants Ezetimibe 5 mg,
Total Cholesterol	180 mg/dL Standard Deviation 35	167 mg/dL Standard Deviation 48

Adverse Events

Ezetimibe 10 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ezetimibe 5 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

Dr. Lawrence Baruch

Bronx VA Medical Center

Phone: 718-584-9000

Email: lawrence.baruch@va.gov

Results disclosure agreements

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