A Study of Ezetimibe/Simvastatin, Atorvastatin, and Rosuvastatin in Patients With or at High Risk of Cardiovascular Disease (CVD)

Condition(s) targeted: Hypercholesterolemia

Intervention: ezetimibe (+) simvastatin (Drug); Comparator: atorvastatin (Drug); Comparator: rosuvastatin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The percentage of patients achieving the target of <2mmol/L at study end

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Merck Sharp & Dohme Ltd., Hoddesdon, Hertfordshire EN11 9BU, United Kingdom; Recruiting
Paul Robinson, Phone: 44 1992 452341

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)

Starting date: March 2007
Last updated: August 6, 2008