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

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

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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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) ]

Measure Type	Primary
Measure Title	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
Measure Description	The primary objective of the study was to assess 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. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MASBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]
Time Frame	Week 4 and week 8 (4 weeks after crossover)
Safety Issue	No

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.
Completers Population: Included all patients who completed both diet periods - high and low sodium diets

Reporting Groups

	Description
Low Sodium Diet	All patients who were on low sodium (<= 100 mmol/day) diet
High Sodium Diet	All patients who were on high sodium (>= 200 mmol/day) diet

Measured Values

	Low Sodium Diet	High Sodium Diet
Number of Participants Analyzed [units: participants]	115	115
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 [units: mm Hg] Mean ± Standard Deviation
Period 1 (4 weeks)	124.8 ± 9.12	134.7 ± 11.13
Period 2 (next 4 weeks after crossover)	123.6 ± 11.69	132.5 ± 10.07

No statistical analysis provided for 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

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) ]

Measure Type	Secondary
Measure Title	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
Measure Description	To evaluate the 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. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MADBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]
Time Frame	Week 4 and week 8 (4 weeks after crossover)
Safety Issue	No

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.
Completers Population: Included all patients who completed both diet periods - high and low sodium diets

Reporting Groups

	Description
Low Sodium Diet	All patients who were on low sodium (<= 100 mmol/day) diet
High Sodium Diet	All patients who were on high sodium (>= 200 mmol/day) diet

Measured Values

	Low Sodium Diet	High Sodium Diet
Number of Participants Analyzed [units: participants]	115	115
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 [units: mm Hg] Mean ± Standard Deviation
Period 1 (4 weeks)	78.5 ± 7.37	85.0 ± 9.06
Period 2 (next 4 weeks after crossover)	78.3 ± 9.10	83.2 ± 8.10

No statistical analysis provided for 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

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) ]

Measure Type	Secondary
Measure Title	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
Measure Description	To evaluate the percentage of responders defined as MASBP < 130 mm Hg or a decrease in MASBP from baseline 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. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. Percent response for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]
Time Frame	Week 4 and Week 8 (4 weeks after crossover)
Safety Issue	No

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.
Completers Population: Included all patients who completed both diet periods - high and low sodium diets

Reporting Groups

	Description
Low Sodium Diet	All patients who were on low sodium (<= 100 mmol/day) diet
High Sodium Diet	All patients who were on high sodium (>= 200 mmol/day) diet

Measured Values

	Low Sodium Diet	High Sodium Diet
Number of Participants Analyzed [units: participants]	115	115
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 [units: Percentage of responders]
Period 1 (4 weeks) - Response	78.0	41.1
Period 1 (4 weeks) - No response	20.3	58.9
Period 2 (next 4 weeks after crossover) - Response	75.0	44.1
Period 2 (next 4 wks after crossover) -No Response	25.0	55.9

No statistical analysis provided for 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

Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial; or the publication of the trial results in their entirety.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

Publications of Results:

Weir MR, Yadao AM, Purkayastha D, Charney AN. Effects of high- and low-sodium diets on ambulatory blood pressure in patients with hypertension receiving aliskiren. J Cardiovasc Pharmacol Ther. 2010 Dec;15(4):356-63. Epub 2010 Sep 27.

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