Efficacy and Safety of Valsartan/Amlodipine Combination in Patients With Severe Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: valsartan/amlodipine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
Summary
This study will assess the effectiveness and safety of different combination antihypertensive
treatments in patients with severe hypertension
Clinical Details
Official title: A Study to Evaluate the Safety and Efficacy of Valsartan/Amlodipine Compared to Lisinopril/Hydrochlorothiazide Given Once Daily for 6 Weeks is Patients With Severe Hypertension
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Adverse events and serious adverse events at each study visit for 6 weeks
Secondary outcome: Sitting and standing blood pressure measurements after 6 weeksLaboratory test data after 6 weeks Vital signs at each study visit for 6 weeks
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with severe hypertension
Exclusion Criteria:
- History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart
rhythm
- Liver, kidney, or pancreas disease
- Insulin dependent diabetes
- Allergy to certain medications used to treat high blood pressure
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Additional Information
Starting date: October 2004
Last updated: June 1, 2006
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