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A Study of Ezetimibe/Simvastatin, Atorvastatin, and Rosuvastatin in Patients With or at High Risk of Cardiovascular Disease (CVD)
This study has been completed.
Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00462748
  Purpose

To evaluate the percentage of patients with either established Cardio Vascular Disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C >2mmol/L, who are able to attain the recommended LDL-C target of <2mmol/L following 6 weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.


Condition Intervention Phase
Hypercholesterolemia
Drug: ezetimibe (+) simvastatin
Drug: Comparator: atorvastatin
Drug: Comparator: rosuvastatin
Phase IV

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Cholesterol
Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin Rosuvastatin calcium Simvastatin Ezetimibe Cholest-5-en-3-ol (3beta)- Vytorin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicentre, Double-Blind, Randomised, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Ezetimibe/Simvastatin 10/40mg, Atorvastatin 40mg, and Rosuvastatin 10mg to Achieve an LDL-C Level of <2mmol/l in Patients With Established CVD or at "High Risk" of Developing CVD, Currently Treated With Simvastatin 40mg and With a Fasting LDL-C 2 Mmol/l

Further study details as provided by Merck:

Primary Outcome Measures:
  • The percentage of patients achieving the target of <2mmol/L at study end [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: March 2007
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Arm 1: Drug
Drug: ezetimibe (+) simvastatin
ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, All tablet form, taken orally, cholesterol lowering medication.
2: Active Comparator
Arm 2: Active comparator
Drug: Comparator: atorvastatin
atorvastatin 40mg. once daily tablet formulation, All tablet form, taken orally.
3: Active Comparator
Arm 3: Active comparator
Drug: Comparator: rosuvastatin
rosuvastatin 10mg. once daily tablet formulation, All tablet form, taken orally.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is male or female and aged over 18
  • Patient provides written informed consent
  • Patient has a fasting ldl-c level >2mmol/l at both visit 1 and again at visit 2
  • Patient has established cvd, diabetes or at "high risk" of cvd (>20 % risk over 10 years, framingham scale)
  • Patient has taken simvastatin 40mg continuously for the past 6 weeks
  • Patient has a fasting triglyceride level of <3.7mmol/l
  • Patient has hba1c <9% at visit 1
  • Patient is 75% compliant with medication between visit 1 and visit 2

Exclusion Criteria:

  • Patient is hypersensitive to any of the study medications or their components
  • Patient has a history of, or active liver disease (persistent elevation of alt / ast (>3xuln)
  • Patient is pregnant, lactating, or a female patient of childbearing potential not using adequate contraception
  • Patient has severe renal impairment: creatinine clearance <30ml/min (Cockcroft-Gault equation) (in patients with moderate renal impairment: <60ml/min, the dose of rosuvastatin will be 5mg in line with the spc)
  • Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e. secondary causes of hyperlipidaemia such as hypothyroidism or hyperthyroidism)
  • Patient has a recent history of, or current, alcohol abuse
  • Patient has ck >10 x uln at visit 1 or visit 2
  • Patient has fasting ldl-c >4.2mmol/l
  • Patient has any acute or serious condition, or history suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, severe endocrine and electrolyte disorders or uncontrolled seizures)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462748

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

(MedWatch - FDA maintained medical product safety Information)  This link exits the ClinicalTrials.gov site
(PhRMA Clinical Study Results Database - web-based repository for clinical study results)  This link exits the ClinicalTrials.gov site
(Merck: Patient & Caregiver U.S. Product Web Site)  This link exits the ClinicalTrials.gov site

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2007_013, MK0653A-121
Study First Received: April 18, 2007
Last Updated: August 12, 2008
ClinicalTrials.gov Identifier: NCT00462748  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Rosuvastatin
Metabolic Diseases
Hyperlipidemias
Simvastatin
Ezetimibe
Metabolic disorder
Hypercholesterolemia
Atorvastatin
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009