Status:
COMPLETED
Safety and Efficacy of Valsartan Plus Hydrochlorothiazide and Amlodipine in Hypertensive Patients
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00426478
Start Date
November 1 2006
End Date
September 1 2007
Last Update
August 22 2008
Active Locations (1)
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1
National Taiwan University
Taipei, R.o.c, Taiwan, 100