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: Men and women hypertensive patients, ages 55 and above. A total of 36 percent were diabetics.
B: Inclusion Criteria:

* Age ≥ 40 years
* History of diabetes mellitus type 2 for at least three months with stable antidiabetic treatment
* Systolic and/or diastolic blood pressure ≥ 135 or 85 mmHg, respectively. In alternative, antihypertensive therapy regardless of blood pressure values
* Serum creatinine ≤ 1.5 mg/dL
* Urinary albumin excretion rate \< 200 µg/min
* Written informed consent for the trial participation.

Exclusion Criteria:

* Clinical or histological evidence of non-diabetic renal disease, including vascular disease of the kidney, obstructive uropathy, prostatic hypertrophy or incomplete bladder emptying
* Transplanted kidney
* Moderate to severe chronic heart failure (III-IV stage according to the NYHA classification).
* Cerebral hemorrhage, stroke or transient ischemic attack within three months prior to the trial enrolment
* Myocardial infarction within three months prior to the trial enrolment
* Unstable angina pectoris
* Mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
* Secondary (e.g., Cushing disease, phaeochromocytoma, etc.) or severe refractory hypertension
* Poor glycemic control (HbA1c\>11%)
* Connective tissue or autoimmune disease
* Hereditary angioneurotic edema
* Clinically relevant electrolyte imbalance (e.g., serum potassium \> 5.5 mmol/L)
* Clinically relevant hematological disorders
* Anemia with hemoglobin concentrations \< 10 g/dL
* Serious hepatic disease
* Pregnancy or lactating or planning a pregnancy
* Women of childbearing potential without following a scientifically accepted form of contraception
* Any other serious or terminal concomitant disease
* Any condition which may interfere with the absorption of the study treatments
* Any concomitant treatment with ACE inhibitors, angiotensin II blockers, calcium channel blockers, potassium sparing diuretics
* Chronic treatment with nonsteroidal antiinflammatory drugs, antidepressants and neuroleptics, lithium, cimetidine, immunosuppressive and/or antineoplastic drugs, chronic systemic glucocorticoid therapy more than 7 consecutive days in one month, antiarrhythmic drugs (e.g., chinidin, procainamide), anesthetics/narcotics
* History of hypersensitivity to delapril or other ACE inhibitors, manidipine or other dihydropyridine CCBs
* Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial
* Evidence of an uncooperative attitude
* Any evidence that allows predicting that the patient will not be able to complete the trial follow-up.
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:

* Clinical diagnosis of hypertension
* Clinical diagnosis of type 2 diabetes or impaired glucose tolerance

Exclusion Criteria:

* History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months.
* Taking calcium channel blocker for the purpose of angina pectoris
* Reduced ejection fraction (\< 40%)
* Second- or third-degree of atrioventricular block
* Severe hypertension (\> 200/110 mmHg) or secondary hypertension
* History of stroke in the recent 6 months
* Serum creatinine \> 2.5 mg/dl
* Estimated survival duration less than 3 years due to other conditions
* Pregnant woman or possibly pregnant woman

Answer: C