Clinical trial NCT01570686: 8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension
Official title: An 8-week Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Oral Aliskiren 300 mg Once Daily Under Light Meal Versus Fasted Condition in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Food effect, hypertension, aliskiren
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-04-04
Enrollment: 589
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

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Primary outcomes:
measure: Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
timeFrame: Baseline, week 8
Secondary outcomes:
measure: Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
timeFrame: Baseline, week 8
measure: Percentage of Patients Achieving Blood Pressure Control
timeFrame: 8 weeks
measure: Change From Baseline (Visit 3) to End of Study (8 Weeks) in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
timeFrame: Baseline, Week 8
measure: Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction
timeFrame: Baseline, Week 8
measure: Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed
timeFrame: Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
measure: Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) in Fasted vs. Fed
timeFrame: Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
measure: Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed
timeFrame: Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)
measure: Change From Baseline to Week 8 in Plasma Renin Activity (PRA)
timeFrame: Baseline, Week 8
measure: Change From Baseline to Week 8 in Plasma Renin Concentration (PRC)
timeFrame: Baseline, Week 8
measure: Number of Patients With Adverse Events, Serious Adverse Events and Death
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Riverside
country: United States
facility: Novartis Investigative Site
state: California
city: Santa Monica
country: United States
facility: Novartis Investigative Site
state: California
city: Walnut Creek
country: United States
facility: Novartis Investigative Site
state: California
city: Westlake Village
country: United States
facility: Novartis Investigative Site
state: California
city: Coral Gables
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: South Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Evansville
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Opelousas
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Chaska
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Edina
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: St. Paul
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Picayune
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Salisbury
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Shelby
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Lyndhurst
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Marion
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Norman
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Eugene
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Oregon City
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Knoxville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Beaumont
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Lake Jackson
country: United States
facility: Novartis Investigative Site
state: Texas
city: Pasadena
country: United States
facility: Novartis Investigative Site
state: Texas
city: Centerville
country: United States
facility: Novartis Investigative Site
state: Utah
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Ettrick
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Midlothian
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Port Orchard
country: United States
facility: Novartis Investigative Site
state: Washington
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: St. John's
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Mirabel
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Pozzilli
country: Italy
facility: Novartis Investigative Site
state: IS
city: Pavia
country: Italy
facility: Novartis Investigative Site
state: PV
city: Sassari
country: Italy
facility: Novartis Investigative Site
state: SS
city: Carolina
country: Puerto Rico
facility: Novartis Investigative Site
city: Cidra
country: Puerto Rico
facility: Novartis Investigative Site
city: Manati
country: Puerto Rico
facility: Novartis Investigative Site
city: Banská Bystrica
country: Slovakia
facility: Novartis Investigative Site
state: Slovak republic
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
state: Slovak republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak republic
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
state: Slovak republic
city: Rimavska Sobota
country: Slovakia
facility: Novartis Investigative Site
state: Slovak republic
city: Senec
country: Slovakia
facility: Novartis Investigative Site
state: Slovak republic
city: Snina
country: Slovakia
facility: Novartis Investigative Site
state: Slovak republic
city: Svidnik
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Trnava
country: Slovakia
facility: Novartis Investigative Site
state: Slovak republic
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Martin
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Sala
country: Slovakia
facility: Novartis Investigative Site
city: Zvolen
country: Slovakia
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Centelles
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Corbera de Llobregat
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Hostalets de Balenya
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Vic
country: Spain
facility: Novartis Investigative Site
state: Cataluña
city: Alzira
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Quart de Poblet
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan, ROC
city: Changhua
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: