The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)

This study has been completed.

Study NCT00423579 Information provided by Schering-Plough

First Received: January 17, 2007 Last Updated: October 13, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment
Conditions:	Hypercholesterolemia Coronary Disease
Interventions:	Drug: Ezetimibe/Simvastatin 10/20 mg Drug: simvastatin 40 mg

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Visits 1 and 2 were for screening, combined if wash-out not required. One ineligible subject mistakenly received assignment at Visit 2 and was removed. The subject did not receive treatment. Actual enrollment: 120 subjects. Intent-to-treat (ITT) population included only evaluable subjects; as such analysis based on 112 subjects.

Reporting Groups

	Description
Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo	Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg	Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.

Participant Flow: Overall Study

	Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo	Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg
STARTED	60^[1]	60
COMPLETED	56^[2]	56^[3]
NOT COMPLETED	4	4
Lost to Follow-up	3	0
Protocol Violation	1	3
Diagnosis of diabetes	0	1

[1]	61 enrolled, however one subject was ineligible and was removed.
[2]	These 56 subjects were the Intent-to-Treat population. Analysis based on ITT population.
[3]	These 56 subjects were the Intent-to-Treat population. Analysis based on ITT population.

Baseline Characteristics

Reporting Groups

	Description
Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo	Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg	Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.

Baseline Measures

	Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo	Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg	Total
Number of Participants [units: participants]	56	56	112
Age^[1] [units: years] Mean ± Standard Deviation	61.3 ± 8.4	62.1 ± 7.8	61.7 ± 8.1
Gender^[2] [units: participants]
Female	26	24	50
Male	30	32	62

[1]	Mean age based on Intent-to-Treat population.
[2]	Gender totals based on Intent-to-Treat population.