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
- Conditions
- hypercholesterolemia and high cardiovascular riskMedDRA version: 9.1 Level: SOC Classification code 10007541 Term: Cardiac disorders
- Registration Number
- EUCTR2006-005513-35-IT
- Lead Sponsor
- MERCK SHARP DOHME
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 520
Visit 1
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.
Visit 2.
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,
at Visit 1
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method