Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Novel Antihypertensive Goal Of hYpertension With diAbetes - Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study
Brief Summary: Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.


Options:
A: 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.
B: 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
C: Inclusion Criteria:

* Demonstrable hypertension defined as mean sitting trough cuff blood pressure ≥ 140/100 mmHg (SeSBP ≥ 140 mmHg and SeDBP ≥ 100mmHg) or mean sitting trough cuff BP ≥ 160/90 mmHg (SeSBP ≥ 160 mmHg and SeDBP ≥ 90mmHg).
* Male or female newly diagnosed hypertensive subjects or currently on hypertension medication.

  * Negative urine pregnancy test at screening
  * Not lactating
  * Do not plan to become pregnant during the study
  * Will practice birth control throughout the study by the following: oral or patch contraceptive, injectable or implantable contraceptive medication, intrauterine device, diaphragm or female condom plus spermicide

    * Non childbearing potential must be classified by one of the following criteria
    * Had a hysterectomy or tubal ligation at least 6 months prior to consent
    * Has been postmenopausal for a least 1 year

Exclusion Criteria:

* Mean sitting trough cuff DBP \<90 mmHg or mean sitting trough cuff SBP \<140 mmHg (off antihypertensive medication).
* Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator).
* Signs or symptoms which could exacerbate the occurrence of hypotension such as volume and salt depletion.
* History of hypertensive encephalopathy, stroke or transient ischemic attack (TIA).
* Participation in another clinical trial involving an investigational drug within one month prior to screening.
* History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina within the past 6 months.
* Any history of New York Heart Association Class III or IV congestive heart failure (CHF). A history of New York Heart Association Class I or II CHF may be exclusionary at the discretion of the investigator.
* History of secondary hypertension including renal disease, pheochromocytoma, or Cushing's syndrome.
* Uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a solitary kidney.
* Evidence of symptomatic resting bradycardia.
* Evidence of hemodynamically significant cardiac valvular disease.
* Presence of heart block greater than first degree atrioventricular block, chronic atrial fibrillation or flutter.
* Uncontrolled Type I or Type II diabetes defined as HbA1c \>9.0%. Diabetics must have documentation of HbA1c within 6 months of the Screening Visit. Undocumented subjects must have their HbA1c assessed prior to randomization. Note: Subjects with Type I or Type II diabetes controlled with insulin, diet or oral hypoglycemic agents on a stable dose for at least 30 days may be included.
* Evidence of liver disease as indicated by ALT and AST and/or total bilirubin \>3 times the upper limit of normal.
* Severe renal insufficiency defined as a creatinine clearance (based on the Cockcroft-Gault formula) of \<30 mL/min.
* Clinically significant laboratory elevations at Visit 1 that compromise subject safety, based on the investigator's judgment. Consideration should take into account the potential laboratory effects of the component blinded therapies.
* Positive for any one of the following tests: hepatitis B surface antigen, hepatitis C antibody (confirmed by radio immunobinding assay, RIBA) or HIV antibody (confirmed by western blot assay).
* Subjects with malignancy during the past 2 years excluding squamous cell or basal cell carcinoma of the skin.
* Known allergy to any of the medications used in the study.
* Subjects who require or are taking any concomitant medication, which may interfere with the objectives of the study (Refer to Section 5.2 for a listing of excluded medications).
* Pregnant or lactating females.
* Current history of drug or alcohol abuse.
* A subject with any medical condition, which in the judgment of the Investigator would jeopardize the evaluation of efficacy or safety and/or constitute a significant safety risk to the subject.
D: Inclusion Criteria:

* Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and \< 120 mmHg, MSSBP ≥ 145 mmHg and \< 200 mmHg).

Exclusion Criteria:

* Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1.
* Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and \< 110 mmHg, and/or MSSBP ≥ 140 mmHg and \< 180 mmHg at Visit 1.
* Patients on four or more antihypertensive drugs at Visit 1.
* Arm circumference \> 42 cm for patients participating in ABPM.

Other protocol-defined exclusion criteria may apply.

Answer: B