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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Valsartan plus Hydrochlorothiazide (80mg/12.5mg) (Drug); Amlodipine (5mg) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Jeremiah CHAO, MD, Principal Investigator, Affiliation: National Taiwan Univ


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.

Clinical Details

Official title: The Comparison of the Antihypertensive Efficacy and Tolerability Between Valsartan Plus Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5mg in the Essential Hypertensive Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks treatment

Secondary outcome:

Change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks treatment

Change from baseline in Ambulatory Blood Pressure Measurement (ABPM) parameters after 8 weeks treatment


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

National Taiwan University, Taipei, R.o.c 100, Taiwan
Additional Information

Starting date: November 2006
Last updated: August 20, 2008

Page last updated: August 23, 2015

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