8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT01570686

CSPP100A2413

2011-005297-36 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.

Enrollment: 589 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy).
• Patients with an office BP ≥ 140/90 mmHg and < 180/110mmHg at the randomization visit and the preceding visit
• Patients must have an absolute difference of ≤ 10 mmHg in both their msSBP and their msDBP between the randomization visit and the preceding visit

Exclusion criteria

• Malignant hypertension or severe hypertension (grade 3 of WHO classification; msSBP ≥180 mmHg or msDBP ≥110 mmHg)
• History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease (PKD).
• Type 1 or Type 2 diabetes mellitus with a fasting glycosylated hemoglobin (HbA1c) > 8%
• Evidence of renal impairment as determined by one of the following: serum creatinine >1.5 x ULN or eGFR < 30 ml/min/1.73m2 at Visit 1, a history of dialysis, or a history of nephrotic syndrome

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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589 participants in 2 patient groups

Aliskiren: Fed

Experimental group

Description:

Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast

Treatment:

Drug: Aliskiren

Aliskiren: Fasting

Experimental group

Description:

Aliskiren 300 mg once daily taken after after an overnight fast

Treatment:

Drug: Aliskiren