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
Results First Received: November 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Intervention: Drug: Aliskiren

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 691 patients enrolled in the study with 590 patients randomized. 1 patient was mis-randomized and did not receive study medication, therefore 589 patients actually received study medication.

Reporting Groups
  Description
Aliskiren: Fed Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
Aliskiren: Fasting Aliskiren 300 mg once daily taken after after an overnight fast

Participant Flow:   Overall Study
    Aliskiren: Fed     Aliskiren: Fasting  
STARTED     296     294  
Safety and Full Analysis Set (FAS)     295 [1]   294  
COMPLETED     274     278  
NOT COMPLETED     22     16  
Abnormal test procedure result(s)                 1                 1  
Administrative problems                 0                 1  
Adverse Event                 8                 6  
Lost to Follow-up                 4                 3  
Protocol Deviation                 3                 0  
Withdrawal by Subject                 4                 4  
Unsatisfactory therapeutic effect                 2                 1  
[1] One patient was mis-randomized and never received study drug. Hence not included in Safety or FAS.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Randomized patients (including one mis-randomized patient in Aliskiren:Fed arm).

Reporting Groups
  Description
Aliskiren: Fed Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
Aliskiren: Fasting Aliskiren 300 mg once daily taken after after an overnight fast
Total Total of all reporting groups

Baseline Measures
    Aliskiren: Fed     Aliskiren: Fasting     Total  
Number of Participants  
[units: participants]
  296     294     590  
Age  
[units: Years]
Mean ± Standard Deviation
  55.7  ± 10.44     56.1  ± 11.03     55.9  ± 10.73  
Gender  
[units: Participants]
     
Female     152     126     278  
Male     144     168     312  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   Percentage of Patients Achieving Blood Pressure Control   [ Time Frame: 8 weeks ]

4.  Secondary:   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 ]

5.  Secondary:   Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction   [ Time Frame: Baseline, Week 8 ]

6.  Secondary:   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) ]

7.  Secondary:   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) ]

8.  Secondary:   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) ]

9.  Secondary:   Change From Baseline to Week 8 in Plasma Renin Activity (PRA)   [ Time Frame: Baseline, Week 8 ]

10.  Secondary:   Change From Baseline to Week 8 in Plasma Renin Concentration (PRC)   [ Time Frame: Baseline, Week 8 ]

11.  Secondary:   Number of Patients With Adverse Events, Serious Adverse Events and Death   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com


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
Results First Received: November 10, 2013
Last Updated: January 15, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Products and Food Branch
Europe: European Medicines Agency
Taiwan: Department of Health