Inegy vs. the Doubling of Atorvastatin in High Risk Patients - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00782184

Purpose

Patients currently taking atorvastatin 20 mg will be switched to either atorvastatin 40mg or ezetimibe/simvastatin 10/40. After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Comparator: ezetimibe/simvastatin 10/40 mg Drug: Comparator: atorvastatin 40 mg Drug: Comparator: atorvastatin 20 mg	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Active-Controlled Study of Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With Atorvastatin: A Comparison of Switching to a Combination Tablet Ezetimibe/Simvastatin Versus Doubling the Baseline Dose of Atorvastatin

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Atorvastatin Atorvastatin calcium Ezetimibe Vytorin

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

percent reduction in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in low-density lipoprotein cholesterol (LDL-C) to <70, <77, <100 mg/dL goals [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	November 2008
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ezetimibe/simvastatin 10/40 mg	Drug: Comparator: ezetimibe/simvastatin 10/40 mg Ezetimibe/simvastatin 10/40 mg tablet once daily for 6 weeks. Drug: Comparator: atorvastatin 20 mg All patients will take atorvastatin 20 mg tablet once daily for the 6 week period before randomization
2: Active Comparator Atorvastatin 40 mg	Drug: Comparator: atorvastatin 40 mg Atorvastatin 40 mg tablet once daily for 6 weeks Drug: Comparator: atorvastatin 20 mg All patients will take atorvastatin 20 mg tablet once daily for the 6 week period before randomization

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are either statin naive or on approved lipid lowering therapy for 6 weeks prior to study initiation
Patient meets ATP III High Risk criteria

Exclusion Criteria:

Females who are pregnant or breastfeeding
Patient consumes more than 14 alcoholic beverages per week
Patient has been treated with an investigational drug within the last 30 days
Patient has congestive heart failure (NYHA Type III or IV)
Patient has congestive heart failure
Patient has had gastric bypass
Patient is newly diagnosed with type 1 or 2 diabetes
Patient is HIV positive
Patient has a history of drug or alcohol abuse within the last 5 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782184

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Colorado
Call for Information	Recruiting
Arvada, Colorado, United States, 80005
Malaysia
Merck Sharp & Dohme (I.A.) Corp	Recruiting
Selangor, Malaysia, 46300
Contact: Nazrin Azli 603-77181748
Peru, Lima
Merck Sharp & Dohme, Peru S.R.L.	Recruiting
Surquillo, Lima, Peru, LIMA 34
Contact: Jorge Vinces 511-411-5933
Poland
MSD Polska Sp. z o.o. Dzial Medyczny	Recruiting
Warszawa, Poland, 00-867
Contact: Adam Czernik 48 22 549-51-39
Romania
MSD Bucharest	Recruiting
Bucharest, Romania, Sector 1
Contact: Marius R. Ursa 4021 316 8353
Spain
Merck Sharp & Dohme De Espana, S.A.E.	Recruiting
Madrid, Spain, 28027
Contact: Jorge Gonzalez-Esteban 34-91-3210-728

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_576, MK0653A-134
Study First Received:	October 29, 2008
Last Updated:	January 27, 2010
ClinicalTrials.gov Identifier:	NCT00782184 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010