A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)

This study has been completed.

Study NCT00783263 Information provided by Merck

First Received on October 30, 2008. Last Updated on August 10, 2011 History of Changes

Results First Received: August 10, 2011

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: Comparator: rosuvastatin 5 mg + ezetimibe 10 mg Drug: Comparator: rosuvastatin 10 mg Drug: Comparator: rosuvastatin 10 mg + ezetimibe 10 mg Drug: Comparator: rosuvastatin 20 mg

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Rosuvastatin 5 mg + Ezetimibe 10 mg	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
Rosuvastatin 10 mg	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
Rosuvastatin 10 mg + Ezetimibe 10 mg	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
Rosuvastatin 20 mg	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.

Participant Flow: Overall Study

	Rosuvastatin 5 mg + Ezetimibe 10 mg	Rosuvastatin 10 mg	Rosuvastatin 10 mg + Ezetimibe 10 mg	Rosuvastatin 20 mg
STARTED	99	98	122	121
COMPLETED	95	96	119	118
NOT COMPLETED	4	2	3	3
Adverse Event	3	0	2	1
Lost to Follow-up	1	1	0	0
Withdrawal by Subject	0	1	1	2

Baseline Characteristics

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Reporting Groups

	Description
Rosuvastatin 5 mg + Ezetimibe 10 mg	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.
Rosuvastatin 10 mg	Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.
Rosuvastatin 10 mg + Ezetimibe 10 mg	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.
Rosuvastatin 20 mg	Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.

Baseline Measures

	Rosuvastatin 5 mg + Ezetimibe 10 mg	Rosuvastatin 10 mg	Rosuvastatin 10 mg + Ezetimibe 10 mg	Rosuvastatin 20 mg	Total
Number of Participants [units: participants]	99	98	122	121	440
Age, Customized [units: participants]
< 65 years	63	62	71	71	267
≥ 65 years	36	36	51	50	173
Gender [units: participants]
Female	35	40	56	37	168
Male	64	58	66	84	272

Outcome Measures

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1. Primary:

Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment [ Time Frame: Baseline to 6 weeks ]

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2. Secondary:

Percent Change From Baseline in LDL-Cholesterol (mg/dL) After 6 Weeks of Treatment in Each Stratum [ Time Frame: Baseline to 6 weeks ]

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3. Secondary:

Number of Participants Who Reached Their Target LDL-C Level [ Time Frame: 6 weeks of treatment ]

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4. Secondary:

Number of Participants in Each Stratum Who Reached Their Target LDL-C Level [ Time Frame: 6 weeks of treatment ]

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5. Secondary:

Number of Participants Who Reached the LDL-C Level of <70 mg/dl [ Time Frame: 6 weeks of treatment ]

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6. Secondary:

Number of Participants in Each Stratum Who Reached the LDL-C Level of <70 mg/dl [ Time Frame: 6 weeks of treatment ]

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7. Secondary:

Percent Change From Baseline in Other Lipid, Lipoprotein, Apolipoprotein and High-sensitivity C-reactive Protein (Hs-CRP)Levels [ Time Frame: Baseline to 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.

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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00783263 History of Changes
Other Study ID Numbers:	MK-0653-139, 2008_567
Study First Received:	October 30, 2008
Results First Received:	August 10, 2011
Last Updated:	August 10, 2011
Health Authority:	United States: Food and Drug Administration