8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension
NCT ID: NCT01570686
Last Updated: 2014-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
589 participants
INTERVENTIONAL
2012-04-30
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aliskiren: Fed
Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
Aliskiren
Aliskiren 300 mg once daily
Aliskiren: Fasting
Aliskiren 300 mg once daily taken after after an overnight fast
Aliskiren
Aliskiren 300 mg once daily
Interventions
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Aliskiren
Aliskiren 300 mg once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
\-
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Los Angeles, California, United States
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Riverside, California, United States
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Santa Monica, California, United States
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Walnut Creek, California, United States
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Westlake Village, California, United States
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Coral Gables, Florida, United States
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Miami, Florida, United States
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South Miami, Florida, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Topeka, Kansas, United States
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Opelousas, Louisiana, United States
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Chaska, Minnesota, United States
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Edina, Minnesota, United States
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Saint Paul, Minnesota, United States
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Jackson, Mississippi, United States
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Picayune, Mississippi, United States
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St Louis, Missouri, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Greensboro, North Carolina, United States
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Salisbury, North Carolina, United States
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Shelby, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Lyndhurst, Ohio, United States
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Marion, Ohio, United States
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Norman, Oklahoma, United States
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Eugene, Oregon, United States
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Oregon City, Oregon, United States
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Portland, Oregon, United States
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Knoxville, Tennessee, United States
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Beaumont, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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Pasadena, Texas, United States
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Centerville, Utah, United States
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Arlington, Virginia, United States
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Ettrick, Virginia, United States
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Midlothian, Virginia, United States
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Port Orchard, Washington, United States
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Moncton, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Brampton, Ontario, Canada
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Toronto, Ontario, Canada
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Mirabel, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Pozzilli, IS, Italy
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Pavia, PV, Italy
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Sassari, SS, Italy
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Carolina, , Puerto Rico
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Cidra, , Puerto Rico
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Manatí, , Puerto Rico
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Banská Bystrica, Slovak Republic, Slovakia
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Bratislava, Slovak Republic, Slovakia
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Košice, Slovak Republic, Slovakia
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Košice, Slovak Republic, Slovakia
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Nitra, Slovak Republic, Slovakia
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Rimavská Sobota, Slovak Republic, Slovakia
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Senec, Slovak Republic, Slovakia
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Snina, Slovak Republic, Slovakia
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Svidník, Slovak Republic, Slovakia
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Trnava, Slovak Republic, Slovakia
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Bratislava, Slovakia, Slovakia
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Martin, Slovakia, Slovakia
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Prešov, Slovakia, Slovakia
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Šaľa, Slovakia, Slovakia
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Zvolen, Slovakia, Slovakia
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Barcelona, Catalonia, Spain
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Centelles, Catalonia, Spain
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Corbera de Llobregat, Catalonia, Spain
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Hostalets de Balenya, Catalonia, Spain
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Vic, Catalonia, Spain
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Madrid, Madrid, Spain
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Alzira, Valencia, Spain
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Quart de Poblet, Valencia, Spain
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Taichung, Taiwan, Taiwan
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Taipei, Taiwan, Taiwan
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Taipei, Taiwan, Taiwan
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Taipei, Taiwan, ROC, Taiwan
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Changhua, , Taiwan
Countries
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Other Identifiers
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2011-005297-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSPP100A2413
Identifier Type: -
Identifier Source: org_study_id
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