Safety and Efficacy of Valsartan Plus Hydrochlorothiazide and Amlodipine in Hypertensive Patients
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Active, not recruiting
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.
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: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks treatment
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.
- 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
- 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
Starting date: November 2006
Last updated: September 12, 2007