A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combination tablet Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary Hypercholesterolemia and High Cardiovascular Risk and Not Adequately Controlled With a Prior Statin Treatment (IN-CROSS) - IN-CROSS

MERCK SHARP DOHME0 个研究点目标入组 520 人开始时间: 2007年5月22日最近更新: 2019年6月30日

试验速览

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•a. Men or women >=18 and <80 years of age,currently taking one of the statins listed below, at one of the specified doses
•below, for at least 6 weeks prior to Visit 1 (Week -6)
•rosuvastatin 5 mg
•simvastatin 20, 40 mg
•atorvastatin 10, 20 mg
•pravastatin 40 mg
•fluvastatin 80 mg
•b. LDL-C level >=100 mg/dL (2.50 mmol/L) and <=190 mg/dL (4.9 mmol/L)
•c.Patient is willing to maintain an NCEP Therapeutic Lifestyle Changes (TLC)/ADA or
•similar cholesterol lowering diet for the duration of the study.
•d. Patient has one or more high cardiovascular risk profiles
•e. Patient has liver transaminases (ALT and AST) <=1.5 X ULN with no active liver
•disease at Visit 2.
•f. Patient has creatine kinase (CK) levels <=3 X ULN.
•a.LDL-C level >=100 mg/dL (2.5 mmol/L) and <=160 mg/dL (4.2 mmol/L)
•b.Patient has triglyceride (TG) concentrations <=350 mg/dL (3.96 mmol/L)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•a. Patient has a hypersensitivity or intolerance to rosuvastatin, ezetimibe or simvastatin
•or any component of these medications.
•b.Female patient who is pregnant or lactating.
•c.Patient has:
•-congestive heart failure defined by NYHA (New York Heart Association)
•Class III or IV;
•- uncontrolled hypertension with systolic blood
•pressure >160 mm Hg or diastolic >100 mm Hg at Visit 1
•-impaired renal function (creatinine >=2.0 mg/dL)
•- endocrine or metabolic disease known to influence serum
•lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, e.g., hypothyroidism,
•-disorders of the hematologic, digestive, or central nervous systems
•that would limit study
•evaluation or participation.
•d.HIV positive
•e. takes following medications: potent inhibitors of CYP3A4, other lipid-lowering drugs in the last 6 (eg niacin) or 8 (eg fibrates) precedint visit 1; corticosteroids.

发起方