Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Morbi-Mortality and Remodeling Study With Valsartan in Patients With Hypertension and Cardiovascular Disease
Brief Summary: The JIKEI HEART Study has been designed to investigate whether concomitant treatment with valsartan, an angiotensin II receptor blocker (ARB), in addition to conventional treatment, will improve the prognosis of 3000 Japanese patients with cardiovascular diseases.


Options:
A: Inclusion Criteria:

* Diabetes mellitus type 2, defined as fasting blood glucose of greater than or equal to 126 mg/dL;
* Presence of at least one of the following cardiovascular risk factors:

  1. total cholesterol greater than 200 mg/dL or statin treatment,
  2. High density lipoprotein (HDL) less than 40 mg/dL,
  3. triglycerides greater than 150 mg/dL and less than 400 mg/dL,
  4. blood pressure greater than or equal to 130/80 mmHg,
  5. Body mass index (BMI) greater than 28 kg/m2,
  6. waist circumference greater than 102 cm for men and greater than 88 cm for women,
  7. smoking of more than 5 cigarettes a day;
* Normoalbuminuria at screening

Exclusion Criteria:

* Severe uncontrolled hyperlipidemia;
* Documented renal and/or renal-vascular disease;
* Myocardial infarction, stroke or myocardial revascularization within the last 6 months;
* History of alcohol and/or drug abuse;
* Allergic reaction, lack of response or contraindication to angiotensin receptor blockers (ARBs);
* Current treatment with an ARB or angiotensin converting enzyme (ACE) inhibitor
B: Inclusion Criteria:

* Clinical diagnosis of hypertension, ischemic heart disease and congestive heart failure

Exclusion Criteria:

* Pregnancy
* Severe renal damage
* Severe liver damage
* Acute myocardial infarction
C: Inclusion Criteria:

* Patients with essential hypertension

Exclusion Criteria:

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of myocardial infarction.
* Other protocol-defined inclusion exclusion criteria also apply.
D: Inclusion criteria:

Male or female subjects 55 year or older who have suffered an ischemic stroke within the past 90 days and who meet all other inclusion criteria. Include also patients of ages 50 - 54 years and/or 90 to 120 days after the qualifying stroke provided the patient has at least two of the following additional risk factors:

* Diabetes mellitus
* Hypertension (systolic BP ¿ 140 or diastolic BP ¿ 90)
* Smoker at time of qualifying stroke
* Obesity (BMI\>30; BMI=weight (kg)/\[height (m)\]2)
* Previous vascular disease (stroke, MI, or peripheral arterial disease prior to qualifying stroke)
* End-organ-damage (retinopathy, LVH, or microalbuminuria)
* Hyperlipidemia

Exclusion criteria:

hemorrhagic stroke (must be ruled out by imaging);unable to give informed consent; known brain tumor, severe renal or hepatic insufficiency, current active peptic ulcer disease, severe coronary artery disease including unstable angina pectoris or an MI within the previous 3 months,or history of a hemostatic disorder or systemic bleeding ;hyperkalemia;uncorrected volume or sodium depletion; pre-stroke history of dementia;modified Rankin score greater than 4;qualifying stroke induced by surgical or cardiovascular procedure;uncontrolled hypertension at entry above 180/110 mmHg (goal BPs are lower); SBP 120 mmHg or less for hospitalized patients; currently taking an ARB and not able or willing to switch to alternative; required or planned continuing treatment with antithrombotics or anticoagulants including heparin or warfarin or non-study platelet inhibitors; syndrome of asthma, rhinitis and nasal polyps;scheduled for major surgery, carotid endarterectomy, or carotid angioplasty (4 weeks post surgery is allowed);unlikely to be released from hospital following the qualifying stroke or presence of a severe disability likely to lead to being bedridden or demented or a non-vascular disease or condition which makes it unlikely that the patient will survive to the end of the trial; history of thrombocytopenia or neutropenia.

Answer: B