A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients

Phase 3CompletedNCT00219076

Novartis504 enrolled

Overview

To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in combination with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 mg.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

504

Conditions

Hypertension

Interventions

aliskirenDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Unnamed facility

Investigative Centers, Germany

Outcomes

Primary Outcomes

Change from baseline in mean sitting diastolic blood pressure after 6 weeks

Secondary Outcomes

Change from baseline in mean sitting systolic blood pressure after 6 weeks

Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 6 weeks

Achieve mean sitting blood pressure target of < 140/90 mmHg after 6 weeks

Change from baseline in standing diastolic blood pressure after 6 weeks

Change from baseline in standing systolic blood pressure after 6 weeks

Data from ClinicalTrials.gov

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