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: January 15, 2014
Last verified: January 2014

April 2, 2012
January 15, 2014
April 2012
November 2012   (final data collection date for primary outcome measure)
Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP) [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
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.
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
Complete list of historical versions of study NCT01570686 on ClinicalTrials.gov Archive Site
  • Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP) [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    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 maDBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.
  • Percentage of Patients Achieving Blood Pressure Control [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Patients achieving blood pressure control were patients who, at week 8, had a mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) < 140/90 mmHg
  • 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) [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    Sitting blood pressure (BP) was measured at trough (approximately 24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the BP was checked in both arms and the arm with higher systolic BP (SBP) was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures (msSBP and msDBP) were measured four times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 2 minute intervals and the mean of all four sitting blood pressure measurements was used as the average sitting office blood pressure for that visit. The analysis of covariance (ANCOVA) model used treatment, region as factors, and baseline as covariate.
  • Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    Successful response in systolic blood pressure reduction at end of 8-week treatment was defined as msSBP <140 mmHg or a reduction in msSBP ≥ 20 mmHg from baseline.
  • Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
  • 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 (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) ] [ Designated as safety issue: No ]
    Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
  • Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
  • Change From Baseline to Week 8 in Plasma Renin Activity (PRA) [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin activity (PRA) . Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8).The difference between baseline and week 8 was calculated.
  • Change From Baseline to Week 8 in Plasma Renin Concentration (PRC) [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin concentration (PRC). Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8). The difference between baseline and week 8 was calculated.
  • Number of Patients With Adverse Events, Serious Adverse Events and Death [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • 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).
Not Provided
Not Provided
 
8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Drug: Aliskiren
Aliskiren 300 mg once daily
Other Name: Tekturna, rasilez
  • Experimental: Aliskiren: Fed
    Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
    Intervention: Drug: Aliskiren
  • Experimental: Aliskiren: Fasting
    Aliskiren 300 mg once daily taken after after an overnight fast
    Intervention: Drug: Aliskiren
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
589
November 2012
November 2012   (final data collection date for primary outcome measure)

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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Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Taiwan,   Canada,   Italy,   Puerto Rico,   Slovakia,   Spain
 
NCT01570686
CSPP100A2413, 2011-005297-36
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP