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

NCT01570686 | Completed Phase 4 Results

• 2 other identifiers: CSPP100A24132011-005297-36
• Study Type: interventional
• Target: 589
• Locations: 7 countries
• Sites: 83

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.

Conditions

Hypertension

Keywords

Food effect, hypertension, aliskiren

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)

  24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maSBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.

  Baseline, week 8

Secondary Outcomes (10)

• Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)

  Baseline, week 8

• Percentage of Patients Achieving Blood Pressure Control

  8 weeks

• 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)

  Baseline, Week 8

• Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction

  Baseline, Week 8

• Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed

  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)

Study Arms (2)

Aliskiren: Fed

EXPERIMENTAL

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

Drug: Aliskiren

Aliskiren: Fasting

EXPERIMENTAL

Aliskiren 300 mg once daily taken after after an overnight fast

Drug: Aliskiren

Interventions

Aliskiren DRUG

Aliskiren 300 mg once daily

Also known as: Tekturna, rasilez

Aliskiren: Fasting; Aliskiren: Fed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (83)

Novartis Investigative Site

Los Angeles, California, 90057, United States

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Novartis Investigative Site

Riverside, California, 92506, United States

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Santa Monica, California, 90404, United States

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Walnut Creek, California, 94598, United States

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Westlake Village, California, 91361, United States

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Coral Gables, Florida, 33134, United States

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Miami, Florida, 33169, United States

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South Miami, Florida, 33143, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60610, United States

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Evansville, Indiana, 47712, United States

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Topeka, Kansas, 66606, United States

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Opelousas, Louisiana, 70570, United States

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Chaska, Minnesota, 55318, United States

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Edina, Minnesota, 55435, United States

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Saint Paul, Minnesota, 55114, United States

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Jackson, Mississippi, 39209, United States

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Picayune, Mississippi, 39466, United States

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St Louis, Missouri, 63141, United States

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Charlotte, North Carolina, 28209, United States

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Greensboro, North Carolina, 27401, United States

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Greensboro, North Carolina, 27408, United States

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Salisbury, North Carolina, 28144, United States

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Shelby, North Carolina, 28152, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45246, United States

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Columbus, Ohio, 43213, United States

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Lyndhurst, Ohio, 44124, United States

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Marion, Ohio, 43302, United States

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Norman, Oklahoma, 73069, United States

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Eugene, Oregon, 97404, United States

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Oregon City, Oregon, 97045, United States

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Portland, Oregon, 97239, United States

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Knoxville, Tennessee, 37920, United States

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Beaumont, Texas, 77702, United States

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Houston, Texas, 77081, United States

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Lake Jackson, Texas, 77566, United States

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Pasadena, Texas, 77504, United States

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Centerville, Utah, 84104, United States

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Arlington, Virginia, 22203, United States

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Ettrick, Virginia, 23803, United States

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Midlothian, Virginia, 23114, United States

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Port Orchard, Washington, 98366, United States

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Moncton, New Brunswick, E1G 1A7, Canada

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St. John's, Newfoundland and Labrador, A1A 3R5, Canada

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Brampton, Ontario, L6T 0G1, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Sainte-Foy, Quebec, G1W 4R4, Canada

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Novartis Investigative Site

Pozzilli, IS, 86077, Italy

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Pavia, PV, 27100, Italy

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Novartis Investigative Site

Sassari, SS, 07100, Italy

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Novartis Investigative Site

Carolina, 00983, Puerto Rico

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Novartis Investigative Site

Cidra, 00739, Puerto Rico

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Novartis Investigative Site

Manatí, 00674, Puerto Rico

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Novartis Investigative Site

Banská Bystrica, Slovak Republic, 97405, Slovakia

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Bratislava, Slovak Republic, 83299, Slovakia

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Košice, Slovak Republic, 040 11, Slovakia

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Košice, Slovak Republic, 04001, Slovakia

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Nitra, Slovak Republic, 95201, Slovakia

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Rimavská Sobota, Slovak Republic, 97901, Slovakia

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Senec, Slovak Republic, 90301, Slovakia

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Snina, Slovak Republic, 09601, Slovakia

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Svidník, Slovak Republic, 08901, Slovakia

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Trnava, Slovak Republic, 91701, Slovakia

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Bratislava, Slovakia, 821 07, Slovakia

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Martin, Slovakia, 036 01, Slovakia

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Prešov, Slovakia, 080 01, Slovakia

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Novartis Investigative Site

Šaľa, Slovakia, 927 03, Slovakia

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Novartis Investigative Site

Zvolen, Slovakia, 960 01, Slovakia

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Novartis Investigative Site

Barcelona, Catalonia, 08905, Spain

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Centelles, Catalonia, 08540, Spain

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Novartis Investigative Site

Corbera de Llobregat, Catalonia, 08757, Spain

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Hostalets de Balenya, Catalonia, 08550, Spain

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Novartis Investigative Site

Vic, Catalonia, 08500, Spain

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Novartis Investigative Site

Madrid, Madrid, 28009, Spain

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Novartis Investigative Site

Alzira, Valencia, 46600, Spain

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Novartis Investigative Site

Quart de Poblet, Valencia, 46930, Spain

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Novartis Investigative Site

Taichung, Taiwan, 40447, Taiwan

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Novartis Investigative Site

Taipei, Taiwan, 10002, Taiwan

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Novartis Investigative Site

Taipei, Taiwan, 114, Taiwan

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Novartis Investigative Site

Taipei, Taiwan, ROC, 112, Taiwan

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Novartis Investigative Site

Changhua, 500, Taiwan

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MeSH Terms

Conditions

Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 4, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 22, 2014
• Results First Posted: January 1, 2014

Record last verified: 2014-01

Locations

TW (5); CA (6); US (43); SL (15); ES (8); IT (3); PR (3)