Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00166504

First received: September 9, 2005

Last updated: March 9, 2009

Last verified: March 2009

Results First Received: October 13, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypercholesterolemia
Interventions:	Drug: ezetimibe (+) simvastatin Drug: atorvastatin

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Phase IV. First Patient Entered 10 Oct 2005. Estimated enrollment = 180. Study conducted at Seoul National University Hospital

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a 4-week diet/wash-out period, patients still at or above drug treatment thresholds established by National Cholesterol Education Program Adult Treatment Panel III Guidelines were randomized. Randomization was stratified according to LDL-C levels obtained 1 week pre-randomization: ≥130 to <160 mg/dL; ≥160 to <190 mg/dL; ≥190 mg/dL.

Reporting Groups

	Description
Vytorin	Ezetimibe 10 mg/Simvastatin 20 mg
Atorvastatin	Atorvastatin 10 mg

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Vytorin	Ezetimibe 10 mg/Simvastatin 20 mg
Atorvastatin	Atorvastatin 10 mg
Total	Total of all reporting groups

Baseline Measures

	Vytorin	Atorvastatin	Total
Number of Participants [units: participants]	108	95	203
Age [units: years] Mean ± Standard Deviation	58.4 ± 10.7	58.7 ± 8.7	58.5 ± 9.8
Gender [units: participants]
Female	57	56	113
Male	51	39	90
Baseline Low Density Lipoprotein Cholesterol (LDL-C) Strata [units: Participants]
<130 mg/dl	2	3	5
>=130 to <160 mg/dl	45	32	77
>=160 to <190 mg/dl	41	43	84
>=190 mg/dl	20	17	37
Body Mass Index [units: kg/m2] Mean ± Standard Deviation	25.3 ± 2.9	25 ± 2.8	25.2 ± 2.8

Outcome Measures

1. Primary:

LDL-C Lowering Efficacy [ Time Frame: 6 weeks ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
No text entered.

Results Point of Contact:

Name/Title: Senior Vice President, Clinical and Quantitative Sciences
Organization: Merck & Co., Inc
phone: 1-800-672-6372

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00166504 History of Changes
Other Study ID Numbers:	2005_070, MK0653A-092
Study First Received:	September 9, 2005
Results First Received:	October 13, 2008
Last Updated:	March 9, 2009
Health Authority:	Korea: Food and Drug Administration