Safety and Efficacy of Valsartan Plus Hydrochlorothiazide and Amlodipine in Hypertensive Patients
Safety and Efficacy of Valsartan Plus Hydrochlorothiazide and Amlodipine in Hypertensive Patients
A double-blind, active-controlled, randomized trial to compare Valsartan plus
 Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5 mg.

 Study design: 2 weeks washout, 8 weeks treatment period.
Inclusion Criteria:

 -  Female or male patient with age ≧ 18 years old.

 -  Patient with mild to moderate uncomplicated essential hypertension, and the blood
 pressure not adequately controlled on existing antihypertensive treatment.

 -  Patient with sitting systolic blood pressure (sSBP)/ sitting diastolic blood pressure
 (sDBP) ≦ 180/110 mmHg at screening visit.

 -  For non-diabetic patient, sitting systolic blood pressure (sSBP) ≧ 140 mmHg or sitting
 diastolic blood pressure (sDBP) ≧ 90 mmHg at baseline visit; for diabetic patient,
 sitting systolic blood pressure (sSBP) ≧ 130 mmHg or sitting diastolic blood pressure
 (sDBP) ≧ 80 mmHg at baseline visit.

 -  Patient or his/her legally acceptable representative has signed and dated the informed
 consent form.

 Exclusion Criteria:

 -  Known or suspected secondary hypertension.

 -  sSBP > 180 mmHg or sDBP > 110 mmHg at baseline visit.

 -  Patients taking more than two anti-hypertensive medications at the screening visit.
 (Fixed-dose combinations of two or more antihypertensive therapies will be counted as
 two or more antihypertensive medications.)

 -  Known NYHA functional class Chronic Heart Failure (CHF) III and IV.

 -  With a history of myocardial infarction, transient ischemic attack or cerebrovascular
 accident within the preceding 6 months, clinically significant valvular heart disease,
 or hepatic and/or renal dysfunction as defined by the following laboratory parameters

 -  SGPT (ALT) or SGOT (AST) > two times upper the limit of normal range

 -  Serum creatinine > 2.3 mg/dl or creatinine clearance < 30 ml/min

 Other protocol-defined inclusion/exclusion criteria may apply