Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Amlodipine Alone

Novartis936 enrolled

Overview

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

936

Conditions

Hypertension

Interventions

valsartan/amlodipineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

Multiple Locations, Germany

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcomes

Change from baseline in systolic blood pressure after 8 weeks

Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks

Diastolic blood pressure less than 90 mmHg after 8 weeks

Data from ClinicalTrials.gov

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