Status:
COMPLETED
8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.
Eligibility Criteria
Inclusion
- Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and \< 120 mmHg, MSSBP ≥ 145 mmHg and \< 200 mmHg).
Exclusion
- Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1.
- Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and \< 110 mmHg, and/or MSSBP ≥ 140 mmHg and \< 180 mmHg at Visit 1.
- Patients on four or more antihypertensive drugs at Visit 1.
- Arm circumference \> 42 cm for patients participating in ABPM.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
2279 Patients enrolled
Trial Details
Trial ID
NCT00327587
Start Date
May 1 2006
End Date
August 1 2007
Last Update
November 8 2011
Active Locations (1)
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1
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey, United States, 07936