Safety and Efficacy of Valsartan Plus Hydrochlorothiazide and Amlodipine in Hypertensive Patients

Novartis

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: Valsartan plus Hydrochlorothiazide (80mg/12.5mg)

Drug: Amlodipine (5mg)

Study type

Interventional

Funder types

Industry

Identifiers

CVAH631BTW02

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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