Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension

Phase 3CompletedNCT00219037

Novartis1,955 enrolled

Overview

Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,955

Conditions

Hypertension

Interventions

aliskirenDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Patients with essential hypertension. 2. Patients who are eligible and able to participate in the study. Exclusion Criteria 1. Severe hypertension. 2. History or evidence of a secondary form of hypertension. 3. History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply.

Locations (1)

Unnamed facility

Investigative Sites, Germany

Outcomes

Primary Outcomes

Adverse events, laboratory abnormalities, serious adverse events

Secondary Outcomes

Change from baseline in mean sitting diastolic blood pressure after 12 months

Change from baseline in mean sitting systolic blood pressure after 12 months

Change from baseline in standing systolic blood and diastolic pressure after 12 months

Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline

Blood pressure less than 140/90 mmHg

Data from ClinicalTrials.gov

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