Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Efficacy and Safety Between Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients With Hypertension: a Randomized Controlled Trial
Brief Summary: The purpose of this study is to compare the effect of fosinopril plus benidipine vs. fosinopril plus hydrochlorothiazide on the renal function during the 6-month treatment in CKD patients with HTN.


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

1. Patients diagnosed with non-dialysis CKD at the enrollment and randomization eGFR≥ 30 ml/min per 1.73 m2 at the enrollment and randomization SBP\> 130 mmHg and/or DBP \> 80 mmHg at the enrollment and randomization. Patients could not receive more than two antihypertensive medications prior to our enrollment, and should discontinue the prior antihypertensive medications after the enrollment according to the investigators' advice.
2. 24 h proteinuria \< 1.5g at the enrollment
3. Patients who signed the informed consent form
4. Baseline serum Cr \< 3 mg/dL at the enrollment and randomization

Exclusion Criteria:

1. Hypertensive crisis (SBP \> 180 mmHg and/or DBP\>110 mmHg)
2. Refractory hypertension (taking \> 2 antihypertensive drugs more than a month, SBP still \> 160mm Hg or DBP \> 100mmHg)
3. Baseline serum Cr \> 3 mg/dl, or kidney transplantation
4. Patients diagnosed as severe cardiac arrhythmia (severe extra beats, supraventricular tachycardias, ventricular arrhythmias, or bradyarrhythmias), heart failure, NYHA \>Ⅲ, angina, stroke, left ventricular hypertrophy or myocardial infarction within 12 months prior to first visit.
5. Patients diagnosed as cancer or severe sepsis
6. Hematological system disorders: myelodysplastic syndrome, granulocytopenia, hypereosinophilic syndrome, polycythemia, thrombocytopenia, and et al.
7. Restrictive pericarditis
8. Systemic Lupus Erythematous
9. Severe diabetes complications such as diabetic ketoacidosis, hyperosmolar coma, retinopathy, amputation, and et al.
10. Patients diagnosed as hyperkalemia(\>5.5mmol/L) within 6 months or at the enrollment
11. Renal artery stenosis or vascular embolism disease
12. Patient is currently pregnant or lactational
13. AST/ALT \> three times of the upper limit of standard value at the baseline
14. Any severe allergy of CCB, diuretic or ACE inhibitor
15. History of severe side effects of CCB, diuretic or ACE inhibitor; long-term use of non-steroidal anti-inflammatory drugs
16. Use of other investigational drugs within 30 days or 5 half-lives of last visit, whichever is longer.
17. Other unsuitable patients judged by the investigators

Answer: D