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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Aliskiren (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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

Percentage of Patients Achieving Blood Pressure Control

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)

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

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

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

Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed

Change From Baseline to Week 8 in Plasma Renin Activity (PRA)

Change From Baseline to Week 8 in Plasma Renin Concentration (PRC)

Number of Patients With Adverse Events, Serious Adverse Events and Death

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

-

Locations and Contacts

Novartis Investigative Site, Carolina 00983, Puerto Rico

Novartis Investigative Site, Cidra 00739, Puerto Rico

Novartis Investigative Site, Manati 00674, Puerto Rico

Novartis Investigative Site, Bratislava 821 07, Slovakia

Novartis Investigative Site, Martin 036 01, Slovakia

Novartis Investigative Site, Presov 080 01, Slovakia

Novartis Investigative Site, Sala 927 03, Slovakia

Novartis Investigative Site, Zvolen 960 01, Slovakia

Novartis Investigative Site, Madrid 28009, Spain

Novartis Investigative Site, Changhua 500, Taiwan

Novartis Investigative Site, Taichung 40447, Taiwan

Novartis Investigative Site, Taipei 10002, Taiwan

Novartis Investigative Site, Taipei 114, Taiwan

Novartis Investigative Site, Los Angeles, California 90057, United States

Novartis Investigative Site, Riverside, California 92506, United States

Novartis Investigative Site, Santa Monica, California 90404, United States

Novartis Investigative Site, Walnut Creek, California 94598, United States

Novartis Investigative Site, Westlake Village, California 91361, United States

Novartis Investigative Site, Barcelona, Cataluña 08905, Spain

Novartis Investigative Site, Centelles, Cataluña 08540, Spain

Novartis Investigative Site, Corbera de Llobregat, Cataluña 08757, Spain

Novartis Investigative Site, Hostalets de Balenya, Cataluña 08550, Spain

Novartis Investigative Site, Vic, Cataluña 08500, Spain

Novartis Investigative Site, Alzira, Comunidad Valenciana 46600, Spain

Novartis Investigative Site, Quart de Poblet, Comunidad Valenciana 46930, Spain

Novartis Investigative Site, Coral Gables, Florida 33134, United States

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Novartis Investigative Site, Pavia, PV 27100, Italy

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Novartis Investigative Site, Sassari, SS 07100, Italy

Novartis Investigative Site, Kosice, Slovak Republic 040 11, Slovakia

Novartis Investigative Site, Svidnik, Slovak Republic 08901, Slovakia

Novartis Investigative Site, Banská Bystrica, Slovak republic 97405, Slovakia

Novartis Investigative Site, Bratislava, Slovak republic 83299, Slovakia

Novartis Investigative Site, Kosice, Slovak republic 04001, Slovakia

Novartis Investigative Site, Nitra, Slovak republic 95201, Slovakia

Novartis Investigative Site, Rimavska Sobota, Slovak republic 97901, Slovakia

Novartis Investigative Site, Senec, Slovak republic 90301, Slovakia

Novartis Investigative Site, Snina, Slovak republic 09601, Slovakia

Novartis Investigative Site, Trnava, Slovak republic 91701, Slovakia

Novartis Investigative Site, Taipei, Taiwan, ROC 112, Taiwan

Novartis Investigative Site, Knoxville, Tennessee 37920, United States

Novartis Investigative Site, Beaumont, Texas 77702, United States

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Novartis Investigative Site, Centerville, Utah 84104, United States

Novartis Investigative Site, Arlington, Virginia 22203, United States

Novartis Investigative Site, Ettrick, Virginia 23803, United States

Novartis Investigative Site, Midlothian, Virginia 23114, United States

Novartis Investigative Site, Port Orchard, Washington 98366, United States

Additional Information

Starting date: April 2012
Last updated: January 15, 2014

Page last updated: August 23, 2015

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