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

Completed · Phase 4

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT01570686

Run by

Novartis Pharmaceuticals

People needed

589

Starts

2012-04-01

Expected to finish

2012-11-01

Last updated by the study team

2014-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Riverside, California, United States
• Novartis Investigative Site — Santa Monica, California, United States
• Novartis Investigative Site — Walnut Creek, California, United States
• Novartis Investigative Site — Westlake Village, California, United States
• Novartis Investigative Site — Coral Gables, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — South Miami, Florida, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Evansville, Indiana, United States
• Novartis Investigative Site — Topeka, Kansas, United States
• Novartis Investigative Site — Opelousas, Louisiana, United States
• Novartis Investigative Site — Chaska, Minnesota, United States
• Novartis Investigative Site — Edina, Minnesota, United States
• Novartis Investigative Site — Saint Paul, Minnesota, United States
• Novartis Investigative Site — Jackson, Mississippi, United States
• Novartis Investigative Site — Picayune, Mississippi, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Greensboro, North Carolina, United States
• Novartis Investigative Site — Greensboro, North Carolina, United States
• Novartis Investigative Site — Salisbury, North Carolina, United States
• Novartis Investigative Site — Shelby, North Carolina, United States
• Novartis Investigative Site — Winston-Salem, North Carolina, United States
• Novartis Investigative Site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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