Status:
COMPLETED
Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension
Lead Sponsor:
Novartis
Conditions:
Stage 2 Systolic Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pr...
Eligibility Criteria
Inclusion
- Male or female outpatient of 18 years of age or greater
- Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (MSSBP) greater than or equal to 160 and \< 200 mmHg at randomization
- Patients who were able to participate in the study, and who gave written informed consent before any study assessment was performed.
Exclusion
- Office systolic blood pressure \>200 and/or mean sitting diastolic blood pressure (MSDBP) greater than or equal to 110 mmHg at Visit 1.
- Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
- Refractory hypertension, defined as blood pressure \>140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
- Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT00931710
Start Date
July 1 2009
End Date
January 1 2010
Last Update
March 7 2011
Active Locations (1)
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1
sites in USA
East Hanover, New Jersey, United States