Status:
COMPLETED
Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential h...
Eligibility Criteria
Inclusion
- Patients who successfully complete the core study (Study CVAA489A1301.
- Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 had to be well controlled defined as MSDBP \< 90 mmHg and MSSBP \< 140 mmHg. At the investigator's or sub-investigator's discretion, those patients who were not well controlled (MSDBP ≥ 90 mmHg or MSSBP ≥ 140 mmHg), and whose MSDBP was \< 100 mmHg and MSSBP was \< 160 mmHg might participate in the extension if this was considered an acceptable level of blood pressure control for the patient.
- Male or female outpatients.
- Patients who have written informed consent to participate in this study.
Exclusion
- Presence of major protocol violation in Study CVAA489A1301.
- Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.
- Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.
- Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or sub-investigator.
- Patients who have gout or gouty arthritis.
- Patients hypersensitive to diuretics (except for potassium sparing diuretics).
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT00446524
Start Date
February 1 2007
End Date
October 1 2008
Last Update
March 28 2017
Active Locations (1)
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1
Novartis Investigative Site
Fukuoka, Japan