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

Phase 3CompletedNCT00219154

Novartis1,125 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

1,125

Conditions

Hypertension

Interventions

aliskirenDRUG

Eligibility

Sex: ALLMin age: 18 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)

Unnamed facility

Investigative Centers, Germany

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Change from baseline in diastolic blood pressure after 26 weeks

Secondary Outcomes

Change from baseline systolic blood pressure after 26 weeks

Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 26 weeks

Achieve blood pressure of < 140/90 mmHg after 26 weeks

Data from ClinicalTrials.gov

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