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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01570686
First received: April 2, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: Aliskiren
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Aliskiren
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline (visit 3) in mean 24 hour ambulatory systolic blood pressure (maSBP) to week 8 [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    24 hour ambulatory blood pressure measurement (ABPM) twice at beginning and end of 8 weeks


Secondary Outcome Measures:
  • Change from baseline (visit 3) in mean 24 hour ambulatory diastolic blood pressure (maDBP) to week 8 [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    24 hour ambulatory blood pressure measurement (ABPM) twice at beginning and end of 8 weeks

  • Proportion of patients achieving blood pressure control [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Patients achieving blood pressure control, which is defined as mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) < 140/90 mmHg, will be compared between treatment groups at Week 8 endpoint

  • Change from baseline (visit 3) in trough mean sitting blood pressure to 8 weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline (visit 3) in trough msSBP and msDBP to week 8

  • Pharmacokinetic of Aliskiren: The observed maximum plasma concentration (Cmax) following drug administration [mass/volume] in fasted vs. fed [ Time Frame: week 4 and week 8 ] [ Designated as safety issue: No ]
    Pharmacokinetic assessment of effect of light meal on aliskiren drug absorption and systemic exposure

  • 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 [ Time Frame: week 4 and week 8 ] [ Designated as safety issue: No ]
    Pharmacokinetic assessment of effect of light meal on aliskiren drug absorption and systemic exposure

  • Pharmacokinetic of Aliskiren: time to reach the maximum concentration (Tmax) after drug administration in fasted vs. fed [ Time Frame: week 4 and week 8 ] [ Designated as safety issue: No ]
    Pharmacokinetic assessment of effect of light meal on aliskiren drug absorption and systemic exposure

  • Change-from baseline of plasma renin activity (PRA) at each timepoint in the biomarker subset [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    Plasma renin activity change from baseline to visit 6 (week 8).


Enrollment: 969
Study Start Date: April 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren 300mg: Fed
Aliskiren 300 mg once daily
 Drug: Aliskiren
Aliskiren 300 mg once daily
Other Name: Tekturna, rasilez
Experimental: Aliskiren 300: Fasting
Aliskiren 300 mg once daily without a light meal (fasted)
 Drug: Aliskiren
Aliskiren 300 mg once daily
Other Name: Tekturna, rasilez

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female outpatients age ≥ 18 years old. A higher age limit will be considered for countries based on their local regulations ( e.g., Taiwan, ≥ 20 years)

    • Patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy).
    • Patients must have 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%
  • Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of aliskiren, including but not limited to, any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active, or active inflammatory bowel syndrome within 12 months prior to Visit 1, regarded as clinically meaningful by the investigator.

Other protocol-defined inclusion/exclusion criteria may apply.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570686

  Show 83 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01570686     History of Changes
Other Study ID Numbers: CSPP100A2413, 2011-005297-36
Study First Received: April 2, 2012
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Products and Food Branch
Europe: European Medicines Agency
Taiwan: Department of Health

Keywords provided by Novartis:
Food effect, hypertension, aliskiren

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013