Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Study Comparing the Incidence of Cardiovascular Events Between High-dose ARB Monotherapy and Combination Therapy With ARB and Calcium Channel Blocker in Japanese Elderly Hypertensive Patients at High Cardiovascular Risk
Brief Summary: The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive patients not adequately controlled by standard dose ARB alone.


Options:
A: Inclusion Criteria:

1. A diagnosis of type 2 diabetes mellitus first made at age 30 years or older
2. Age 55 years or older at entry
3. Ability to provide informed consent
4. A substantially elevated risk of cardiovascular disease, indicated by:

   * A history of major macrovascular disease defined as any one of: stroke, myocardial infarction, hospital admission for transient ischaemic attack, hospital admission for unstable angina, coronary artery bypass graft, percutaneous transluminal coronary angioplasty (with or without stenting), peripheral revascularisation (angioplasty or surgery) or amputation secondary to vascular disease or
   * A history of major microvascular disease defined as any one of nephropathy (albumin:creatinine ratio \>300ug/mg), retinal photocoagulation therapy, proliferative retinopathy (new blood vessels on the disc or elsewhere, vitreous haemorrhage, pre-retinal haemorrhage, or fibrous proliferations on the disc or elsewhere), macular oedema (retinal thickening within one disc diameter of the macular centre) or blindness in either eye (corrected visual acuity 6/60 or worse, persisting for three months or more) not known to be due to non-diabetic causes or
   * A first diagnosis of type 2 diabetes made 10 or more years prior to entry or
   * Another major risk factor for vascular disease defined as any one of: current daily cigarette smoking, total cholesterol greater than 6.0 mmol/l (with or without cholesterol lowering treatment), HDL cholesterol \<1.0 mmol/l, microalbuminuria (albumin:creatinine ratio 30-300ug/mg) or
   * Age 65 years or over

Exclusion Criteria:

1. A definite contraindication to treatment with an ACE inhibitor or a thiazide-like diuretic
2. A specific indication for treatment with an ACE inhibitor other than perindopril 2-4 mg daily (see also section 5.2.3) or a thiazide-like diuretic
3. A definite and specific indication for treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less
4. A definite contra-indication to treatment with gliclazide or a haemoglobin A1c control target of 6.5% or less
5. A definite indication for long-term full-dose or bed-time insulin therapy
6. Participation in a trial within the month prior to the Registration Visit or current participation in another trial

Other potential reasons for ineligibility include:

* High probability of non-adherence to study treatment or follow-up
* Current clinical instability (e.g. a major cerebral or coronary event or sight-threatening retinopathy or macular oedema within the previous few weeks)
* Life threatening non-vascular disease other than diabetes and its complications
* Moderate or severe dementia
* Major disability that is likely to prevent regular attendance at study clinics

Final decisions about eligibility were made at the discretion of the study investigator and the potential study participant, in the light of any requirements or guidance from local ethics committees and other regulatory bodies.
B: Inclusion Criteria:

* Visited Duke General Internal Medicine Primary Care Clinic at Pickett Road or Duke Outpatient Clinic between April 2003 and April 2004
* Diagnosed with high BP
* Currently residing in an eight county area, including Durham County, NC and surrounding counties
* Currently taking BP medication
* Receives most medical care at the Duke Primary Care clinics
* Able to speak and understand English over the phone

Exclusion Criteria:

* Diagnosed with dementia
* Diagnosed with Parkinson's Disease
* Diagnosed with atrial fibrillation
* Diagnosed with end stage kidney disease
* Hospitalized for stroke, heart attack, or coronary artery revascularization in the 3 months prior to study entry
* Diagnosed with metastatic cancer in the 3 months prior to study entry
* Receiving kidney dialysis
* Pregnant or expecting to become pregnant in the 2 years following study entry
* Currently residing in a nursing home or receiving home health care
* Severely impaired speech or hearing
* Participating in another blood pressure study
* Has another family member participating in this study
C: Inclusion Criteria:

* Outpatients aged 65 years or older, and less than 85 years (at the time of informed consent), regardless of sex
* Current antihypertensive treatment with monotherapy
* SBP ≥ 140mmHg or DBP ≥ 90mmHg in a sitting position on two measurements on two clinic visits
* At least one of the following risk factors:

  * Diabetes mellitus Type 2;
  * History of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack (more than 6 months before giving informed consent);
  * Diagnosis of asymptomatic cerebrovascular disease;
  * History of myocardial infarction (more than 6 months before giving informed consent);
  * Diagnosis of angina pectoris or heart failure (New York Heart Association \[NYHA\] functional classification I or II);
  * Diagnosis of left ventricular hypertrophy (thickness of the wall of interventricular septum ≥ 12mm on echocardiography or Sv1+Rv5 ≥ 35mm on electrocardiography before informed consent);
  * Diagnosis of aortic aneurysm;
  * History of aortic dissection (more than 6 months before giving informed consent);
  * Diagnosis of arteriosclerotic peripheral arterial obstruction (Fontaine classification from 2 to 4);
  * Serum creatinine: 1.2-2.5mg/dL (male); 1.0-2.5mg/dL (female);
  * Proteinuria: ≥ +1 (or ≥ 0.3g/g･Cr. estimated from 24-hour urine collection or random urinary protein corrected by urine creatinine).

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Heart failure (NYHA functional classification III or IV)
* Required treatment for malignant tumor
* Serious liver or renal dysfunction (serum creatinine \> 2.5mg/dL or with dialysis treatment)
* Not appropriate for change to the test drugs from current therapy for hypertension or coronary diseases (i.e. calcium channel blockers, β-blockers, thiazide diuretics, etc.)
* History of serious adverse drug reactions to angiotensin II receptor blockers or calcium channel blockers
* Patients with other serious reasons (i.e. illness, significant abnormalities, etc.) that investigators judge inappropriate for the study
D: 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

Answer: C