Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Placebo; Drug: Aliskiren 300 mg; Drug: Aliskiren 75 mg; Drug: Aliskiren 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00706134

CSPP100A2405

Details and patient eligibility

About

This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.

Enrollment: 756 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female outpatients 65 years of age and older.
• Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
• At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.

Exclusion criteria

• Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg].
• History or evidence of a secondary form of hypertension.
• Known Keith-Wagener grade III or IV hypertensive retinopathy.
• History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
• Current diagnosis of heart failure (NYHA Class II-IV).
• History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
• Current angina pectoris requiring pharmacological therapy other than nitrates.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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756 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Aliskiren 75 mg

Experimental group

Treatment:

Drug: Aliskiren 75 mg

Aliskiren 150 mg

Experimental group

Treatment:

Drug: Aliskiren 150 mg

Aliskiren 300 mg

Experimental group

Treatment:

Drug: Aliskiren 300 mg