Please select the eligibility criteria that correspond to the clinical trial below.
Title: Valsartan in Elderly Isolated Systolic Hypertension
Brief Summary: The aim of this study is to compare the incidence of cardiovascular events between two target systolic blood pressure levels, below 140 mmHg and below 150 mmHg under treatment with valsartan in elderly isolated systolic hypertensive patients in Japan.


Options:
A: Inclusion Criteria:

* At least 55 years of age.
* Previously untreated or treated hypertension.
* For patients \>= 60 years, evidence of at least one CV disease or target organ damage, or for patients 55-59 years evidence of at least two CV diseases or target organ damage from two different organ systems as defined in the protocol.

Exclusion Criteria:

* Allergy to any of the drugs administered in this trial.
* Current angina pectoris (ie, no anginal event requiring NTG within 1 month prior to Visit 1).
* Secondary hypertension.
* Refractory hypertension defined as SBP \>= 180 mmHg and/or DBP \>= 110 mmHg unresponsive to triple-drug regimens of sympatholytics, diuretics and vasodilators.
* History of symptomatic heart failure (NYHA classes II-IV) or ejection fraction \< 40%.
* Myocardial infarction, coronary revascularization (CABG or PCI), unstable angina within one month of Visit 1.
* Stroke or transient ischemic event (TIA) within 3 months of Visit 1.
* Significant obstructive valvular cardiovascular disease or any valvular disease expected to lead to surgery during the course of the study.
* Evidence of hepatic disease (AST or ALT values \>= 2 X upper limit of normal).
* Impaired renal function (serum creatinine \>= 2.5 mg/dL (221 µmol/L)).
* Baseline serum potassium of \> 5.2 meq/L not on potassium supplements.
* History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the last 5 years.
* History of clinically significant auto immune disorders such as Systemic Lupus Erythematosus.
* Significant non-cardiovascular illness or condition likely to result in death prior to trial completion, e.g., major organ transplant (life expectancy \<5 years).
* Significant cardiovascular disease such as an aortic aneurysm ≥ 6 cm, likely requiring surgical intervention during the course of the study.

Other protocol-defined exclusion criteria applied to the study.
B: Inclusion Criteria:

1. Systolic BP between 140-190 mm Hg in the three screening visits or currently under anti-hypertension treatment；
2. An age of 60 - 80 years old；
3. Signed the written informed consent.

Exclusion Criteria:

1. Systolic BP≥190 mm Hg, or diastolic BP \<60 mm Hg;
2. Known secondary cause of hypertension;
3. History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not lacunar infarction and transient ischemic attack \[TIA\]);
4. Hospitalization for myocardial infarction or unstable angina within the previous 6 months;
5. Coronary revascularization (PCI or CABG) within the previous 12 months;
6. Planned to perform coronary revascularization (PCI or CABG) in the future 12 months;
7. History of sustained atrial fibrillation or Ventricular arrhythmias at entry influencing the measurement of electronic blood pressure；
8. NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months;
9. Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial;
10. Dilated or hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease;
11. Uncontrolled diabetes (serum fasting glucose ≥200 mg/dl \[11.1 mmol/L\], HbA1\>8%);
12. Lab tests indicating abnormal liver or kidney function (ALT more than 3 times the upper limit of normal value, or end stage renal disease (ESRD) on dialysis, or estimated glomerular filtration rate (eGFR) \<30 mL/min, or serum creatine \>2.5 mg/dl \[\>221 umol/L\];
13. Severe somatic disease such as cancer;
14. Severe cognitive impairment or mental disorders;
15. Participating in other clinical trials.
C: Inclusion Criteria:

* At least 50 years old

Systolic blood pressure of

* 130 - 180 mm Hg on 0 or 1 medication
* 130 - 170 mm Hg on up to 2 medications
* 130 - 160 mm Hg on up to 3 medications
* 130 - 150 mm Hg on up to 4 medications

Risk (one or more of the following)

1. Presence of clinical or subclinical cardiovascular disease other than stroke
2. CKD, defined as eGFR 20 - 59 ml/min/1.73m2
3. A Framingham Risk Score for 10-year CVD risk ≥ 15%
4. Age greater than 75 years

Exclusion Criteria:

* An indication for a specific BP lowering medication that the person is not taking and the person has not been documented to be intolerant of the medication class.
* Known secondary cause of hypertension that causes concern regarding safety of the protocol.
* One minute standing SBP \< 110 mm Hg.
* Proteinuria in the following ranges (based on a measurement within the past 6 months)

  * 24 hour urinary protein excretion ≥1 g/day, or
  * 24 hour urinary albumin excretion ≥ 600 mg/day, or
  * spot urine protein/creatinine ratio ≥ 1 g/g creatinine, or
  * spot urine albumin/creatinine ratio ≥ 600 mg/g creatinine, or
  * urine dipstick ≥ 2+ protein
* Arm circumference too large or small to allow accurate blood pressure measurement with available devices
* Diabetes mellitus,
* History of stroke (not CE or stenting)
* Diagnosis of polycystic kidney disease
* Glomerulonephritis treated with or likely to be treated with immunosuppressive therapy
* eGFR \< 20 ml/min /1.73m2 or end-stage renal disease (ESRD)
* Cardiovascular event or procedure (as defined above as clinical CVD for study entry) or hospitalization for unstable angina within last 3 months
* Symptomatic heart failure within the past 6 months or left ventricular ejection fraction (by any method) \< 35%
* A medical condition likely to limit survival to less than 3 years or a malignancy other than non-melanoma skin cancer within the last 2 years
* Any factors judged by the clinic team to be likely to limit adherence to interventions.
* Failure to obtain informed consent from participant
* Currently participating in another clinical trial (intervention study). Note: Patient must wait until the completion of his/her activities or the completion of the other trial before being screened for SPRINT.
* Living in the same household as an already randomized SPRINT participant
* Any organ transplant
* Unintentional weight loss \> 10% in last 6 months
* Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control.
D: Inclusion Criteria:

* Outpatients aged over 70 years and less than 85 years, regardless of sex.
* Patients with stable seated systolic blood pressure of over 160 mmHg and diastolic blood pressure of less than 90 mmHg at two visits within 2 to 4 weeks.
* Previously untreated patients or patients who are on other therapy that can be converted to valsartan.

Exclusion Criteria:

* Patients with secondary hypertension or malignant hypertension.
* Patients with seated systolic blood pressure of over 200 mmHg.
* Patients with seated diastolic blood pressure of over 90 mmHg.
* Patients with a history of cerebrovascular disorder or myocardial infarction within 6 months prior to enrolment in the study.
* Patients who underwent coronary arterioplasty within 6 months prior to enrolment in the study or patients who will undergo coronary arterioplasty within 6 months after entry.
* Patients with severe heart failure (NYHA functional classification III and IV).
* Patients with severe aortic stenosis or valvular disease.
* Patients with atrial fibrillation, atrial flutter, or serious arrhythmia.
* Patients with renal dysfunction with serum creatinine level of over 2 mg/dL.
* Patients with serious liver dysfunction.
* Patients with a history of hypersensitivity to valsartan.
* Other patients who are judged to be inappropriate for the study by the investigator or sub-investigator.

Answer: D