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Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00441064
First received: February 26, 2007
Last updated: February 28, 2011
Last verified: February 2011
Results First Received: December 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover 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
A total of 132 patients were randomly assigned to one of the two diet sequences: 69 in the low/high and 63 in the high/low diet sequence. After 4 wks on the assigned diet, patients were then crossed over to the other diet. Patients who were on a high sodium diet for the first 4 wks started on a low sodium diet for the next 4 wks vice versa.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Safety Population (SP) -Included all randomized patients who received at least 1 dose of study medication. Intent-to-treat population (ITT) -All randomized patients who received at least 1 dose of study medication and had at least 1 valid post baseline assessment of primary efficacy variable.

Reporting Groups
  Description
Diet Sequence Low/High Sodium Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks who crossed over to the high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
Diet Sequence High/Low Sodium Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and crossed over to the low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]

Participant Flow:   Overall Study
    Diet Sequence Low/High Sodium     Diet Sequence High/Low Sodium  
STARTED     69     63  
Safety Population (SP)     69     63  
Intent-to-treat (ITT) Population     61     57  
COMPLETED     59     56  
NOT COMPLETED     10     7  
Adverse Event                 1                 0  
Abnormal laboratory values                 0                 2  
Abnormal test procedure results                 0                 1  
Unsatisfactory therapeutic effect                 1                 0  
Protocol Deviation                 3                 2  
Patient withdrew consent                 5                 2  



  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.
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Reporting Groups
  Description
Diet Sequence Low/High Sodium Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks and high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
Diet Sequence High/Low Sodium Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and on low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]
Total Total of all reporting groups

Baseline Measures
    Diet Sequence Low/High Sodium     Diet Sequence High/Low Sodium     Total  
Number of Participants  
[units: participants]
  69     63     132  
Age  
[units: years]
Mean ± Standard Deviation
  51.0  ± 7.16     52.1  ± 7.75     51.5  ± 7.44  
Gender  
[units: participants]
     
Female     34     25     59  
Male     35     38     73  
MSSBP [1]
[units: mm Hg]
Mean ± Standard Deviation
  147.6  ± 9.21     146.2  ± 8.94     146.9  ± 9.07  
MSDBP [2]
[units: mm Hg]
Mean ± Standard Deviation
  92.7  ± 9.81     93.6  ± 8.33     93.1  ± 9.11  
MASBP [3]
[units: mm Hg]
Mean ± Standard Deviation
  138.7  ± 8.30     139.1  ± 8.52     138.9  ± 8.38  
MADBP [4]
[units: mm Hg]
Mean ± Standard Deviation
  86.6  ± 6.73     87.7  ± 7.28     87.1  ± 6.99  
[1] Mean Sitting Systolic Blood Pressure (MSSBP)
[2] Mean Sitting Diastolic Blood Pressure (MSDBP)
[3] Mean Ambulatory Systolic Blood Pressure (MASBP)
[4] Mean Ambulatory Diastolic Blood Pressure (MADBP)



  Outcome Measures
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1.  Primary:   Mean 24 Hour Ambulatory Systolic Blood Pressure (MASBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet   [ Time Frame: Week 4 and week 8 (4 weeks after crossover) ]

2.  Secondary:   Mean 24 Hour Ambulatory Diastolic Blood Pressure (MADBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet   [ Time Frame: Week 4 and week 8 (4 weeks after crossover) ]

3.  Secondary:   Percentage of Responders Defined as MASBP <130 mm Hg or a Decrease From Baseline in MASBP of ≥20 mm Hg in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet   [ Time Frame: Week 4 and Week 8 (4 weeks after crossover) ]


  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


Publications of Results:

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00441064     History of Changes
Other Study ID Numbers: CSPP100AUS02
Study First Received: February 26, 2007
Results First Received: December 15, 2010
Last Updated: February 28, 2011
Health Authority: United States: Institutional Review Board