A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazide Based Treatment Regimen With Optional Addition of Amlodipine

Novartis976 enrolled

Overview

This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

976

Conditions

Hypertension

Interventions

AliskirenDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with essential hypertension Exclusion Criteria: * Severe hypertension * History or evidence of a secondary form of hypertension * History of myocardial infarction. * Other protocol-defined inclusion exclusion criteria also apply.

Locations (2)

Novartis

East Hanover, New Jersey, United States

Unnamed facility

Investigative Centers, Germany

Outcomes

Primary Outcomes

Change from baseline in diastolic blood pressure after 52 weeks

Secondary Outcomes

Change from baseline in systolic and diastolic blood pressure after 52 weeks

Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks

Achieve blood pressure control target of < 140/90 mmHg after 12 weeks

Data from ClinicalTrials.gov

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