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Clinical trial

A Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of Valsartan/Amlodipine 160/10 mg Versus Amlodipine 10 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Amlodipine 10 mg Monotherapy

ID
Name
CVAA489A2306
Description
This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication
Trial arms
Trial start
2004-11-01
Estimated PCD
2005-06-01
Trial end
2005-06-01
Status
Completed
Phase
Early phase I
Treatment
valsartan/amlodipine
Size
936
Primary endpoint
Change from baseline in diastolic blood pressure after 8 weeks
Eligibility criteria
Inclusion Criteria: * Patients with uncomplicated, essential hypertension Exclusion Criteria: * Severe hypertension * 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 exclusion criteria may apply.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}, 'enrollmentInfo': {'count': 936, 'type': 'ACTUAL'}}
Updated at
2023-12-14

1 organization

1 product

1 indication

Product
valsartan/amlodipine
Indication
Hypertension
Organization
Novartis