Status:
COMPLETED
Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy
Lead Sponsor:
Novartis
Conditions:
Hypertension; Hypertrophy, Left Ventricular
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy
Eligibility Criteria
Inclusion
- Caucasian; male or female outpatients and age between 18-80 years of age, inclusive.
- Patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy and with a diastolic blood pressure \>=90 and \<= 105mmHg or with a combination therapy (limited to two active compounds) and with a diastolic blood pressure of \>=90 and \<= 100mmHg.
- Patients with Left Ventricular Hypertrophy
Exclusion
- Severe hypertension
- Symptomatic heart failure
- History of stroke, heart attack, coronary bypass surgery etc.
- Insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00446563
Start Date
March 1 2007
End Date
March 1 2010
Last Update
May 11 2011
Active Locations (1)
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1
25 centers in Germany
Ludwigshafen, Germany