Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Lipid-Altering Efficacy and Safety of the Ezetimibe/Simvastatin Combination Tablet Versus Rosuvastatin in Patients With Primary Hypercholesterolemia
Brief Summary: A 10-week study to compare the reduction in cholesterol following treatment with two different marketed drugs in patients with hypercholesterolemia.


Options:
A: Inclusion Criteria:

* Visit 1:

  1. Written informed consent to participate in the trial (Appendix B)
  2. Male or female subjects, age \> 18 years
  3. Primary hypercholesterolaemia with CV risk \> 20%/10yrs, type 2 diabetes, a history of CHD or other established atherosclerotic disease (definition given in Appendix L).
  4. Subjects may be lipid-lowering therapy-naïve, but have completed 6-weeks dietary counselling before this visit OR Subjects may be treated with the 'start' dose of other lipid lowering therapy, which is ineffective, ie. The subject has not met LDL-C treatment goals.
  5. Subjects willing to follow all study procedures including attendance at clinics for scheduled study visits, fasting prior to blood draws and compliance with study treatment regimen

     Visit 2:
  6. Subjects switched from start dose of a lipid lowering therapy (commonly accepted start dose) will have fasting LDL-C levels \> 3.1 mmol (120 mg/dl)
  7. Newly treated subjects, after a six-weeks dietary counselling, will have fasting LDL-C levels \> 3.5 mmol/L (135 mg/dL)
  8. Fasting triglycerides £ 4.52 mmol/L (400 mg/dL)
  9. Switched patients must stop current lipid lowering treatment at randomisation (Visit 2)

Exclusion Criteria:

1. Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
2. Documented secondary hypercholesterolaemia of any cause other than named in inclusion criteria 3
3. History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy
4. Unstable angina within three months prior to inclusion in the study
5. Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT ³ 1.5 times the ULN. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the subject must not be included in the study
6. Known uncontrolled diabetes
7. Uncontrolled hypertension defined as either resting diastolic blood pressure of \> 95mmHg or resting systolic blood pressure of \> 200 mmHg
8. Unexplained serum CK \> 3 times ULN (eg not due to recent trauma, intramuscular injections, heavy exercise etc)
9. Serum creatinine \> 220 µmol/L (2.5mg/dL)
B: Inclusion Criteria:

* Subjects with mixed dyslipidemia
* Subjects agree to utilize adequate birth control methods and to adhere to the American Heart Association (AHA) diet.

Exclusion Criteria:

* Subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial.
* Patients who are taking certain medications or unstable dose of specific medications.
* Women who are pregnant or plan on becoming pregnant, or women who are lactating.
C: Inclusion Criteria:

* Patients older than 18 years, both genders, without any previous treatment with statins or other lipid lowering drugs for at least 6 months
* With elevated triglycerides above 200 and below 800mg/dl and willing to follow all study procedures including assisting to clinics, fasting before blood samples and signing a written consent

Exclusion Criteria:

* High levels of low-density lipoprotein cholesterol (LDL-C)
* Unstable cardiovascular condition or awaiting a myocardial revascularization
* Congestive cardiac failure
* Uncontrolled diabetes
* Cancer
* Uncontrolled hypothyroidism
* Familial hypercholesterolemia
* Liver/muscle disease
* Pregnancy
* Other
D: Men and women aged 18 to 69 years, with elevated cholesterol levels may be eligible to participate in a research study to assess the efficacy and safety of two marketed drugs.

Answer: D