Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

Novartis79 enrolled

Overview

Essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. It contributes to cardiovascular disease development, a major and well established risk factor. A patient non compliant to drug therapy is recognized as one of the primary reasons for inadequate blood pressure control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

valsartanDRUG

amlodipineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion criteria * MSSBP\> 140 mm Hg, and/or MSDBP\> 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at end of core study Exclusion criteria * Premature discontinuation in the core study or failure to comply with the core study protocol * Any patient that the investigator decides should not participate in the extension Other protocol-defined inclusion/exclusion criteria may apply

Locations (2)

Unnamed facility

Investigative Centers, Germany

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 22 weeks

Secondary Outcomes

Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 14 and 22 weeks

Adverse events after 22 weeks

Data from ClinicalTrials.gov

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