A Clinical Study to Assess Efficacy and Safety of Aliskiren in the Elderly With High Blood Pressure

Phase 3CompletedNCT00219167

Novartis355 enrolled

Overview

After a wash-out (1 to 2 weeks), and 2 to 4 week single-blind placebo run-in period, eligible patients will be randomized to receive lisinopril 10 mg, aliskiren 75 mg, 150 mg or 300 mg for a period of 8 weeks

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

355

Conditions

Hypertension

Interventions

aliskirenDRUG

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria * Patients with at least 65 years-old * Patients with essential hypertension Exclusion Criteria * Severe hypertension * History or evidence of a secondary form of hypertension * History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.

Locations (1)

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Change from baseline in average 24 hour systolic ambulatory blood pressure after 8 weeks

Secondary Outcomes

Change from baseline in average 24 hour diastolic ambulatory blood pressure after 8 weeks

Change from baseline in sitting systolic and diastolic blood pressure after 8 weeks

Change from baseline in daytime diastolic ambulatory blood pressure after 8 weeks

Change from baseline in daytime systolic ambulatory blood pressure after 8 weeks

Blood pressure control target of < 140/90 mmHg after 8 weeks

Data from ClinicalTrials.gov

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