A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments.

This study has been completed.

Study NCT00462748 Information provided by Merck

First Received on April 18, 2007. Last Updated on April 20, 2010 History of Changes

Results First Received: May 7, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Hypercholesterolemia
Interventions:	Drug: ezetimibe (+) simvastatin Drug: Comparator: atorvastatin Drug: Comparator: rosuvastatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with diabetes, cardiovascular disease (CVD) or a “high risk” of developing CVD and a fasting LDL-C level of ≥2mmol/l, having been on simvastatin 40mg for 6 weeks were assigned to 10/40 mg ezetimibe/simvastatin; 40 mg atorvastatin; 10 mg rosuvastatin (5 mg in elderly/Asian patients (in line with UK SPC)) between 27/03/2007 and 31/03/2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients were subjected to a 6 week run-in period on open label 40 mg simvastatin to stabilise their LDL-C levels. Patients whose LDL-C at the end of this period was below 2.0 mmol/l or who were <75% compliant with run-in medication, were excluded from the study

Reporting Groups

	Description
Ezetimibe/Simvastatin	ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
Atorvostatin	atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
Rosuvastatin	rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally

Participant Flow: Overall Study

	Ezetimibe/Simvastatin	Atorvostatin	Rosuvastatin
STARTED	261	263	262
COMPLETED	249	252	251
NOT COMPLETED	12	11	11
Adverse Event	7	5	9
Protocol Violation	0	2	1
Withdrew consent	3	3	0
Lost to Follow-up	1	1	1
Discontinued after 41 days Rx	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Ezetimibe/Simvastatin	ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
Atorvostatin	atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
Rosuvastatin	rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally

Baseline Measures

	Ezetimibe/Simvastatin	Atorvostatin	Rosuvastatin	Total
Number of Participants [units: participants]	261	263	262	786
Age [units: years] Mean ± Standard Deviation	64.7 ± 8.65	64.2 ± 8.44	63.9 ± 8.61	64.3 ± 8.56
Age, Customized [units: participants]
< 70 years	185	187	195	567
>=70 years	76	76	67	219
Gender [units: participants]
Female	101	78	84	263
Male	160	185	178	523
Race/Ethnicity, Customized [units: Participants]
Asian	3	0	2	5
White	254	261	257	772
Black	4	0	2	6
Other	0	2	1	3

Outcome Measures

1. Primary:

Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End [ Time Frame: 6 Weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided by Merck

Publications automatically indexed to this study:

McCormack T, Harvey P, Gaunt R, Allgar V, Chipperfield R, Robinson P; IN-PRACTICE study. Incremental cholesterol reduction with ezetimibe/simvastatin, atorvastatin and rosuvastatin in UK General Practice (IN-PRACTICE): randomised controlled trial of achievement of Joint British Societies (JBS-2) cholesterol targets. Int J Clin Pract. 2010 Jul;64(8):1052-61. Epub 2010 May 12.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00462748 History of Changes
Other Study ID Numbers:	2007_013, MK0653A-121
Study First Received:	April 18, 2007
Results First Received:	May 7, 2009
Last Updated:	April 20, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency