Trial Outcomes & Findings for Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren (NCT NCT00441064)
NCT ID: NCT00441064
Last Updated: 2011-03-25
Results Overview
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. \[At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MASBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).\]
COMPLETED
PHASE4
132 participants
Week 4 and week 8 (4 weeks after crossover)
2011-03-25
Participant Flow
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.
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.
Participant milestones
| Measure |
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. \[with Aliskiren 300 mg\]
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
63
|
|
Overall Study
Safety Population (SP)
|
69
|
63
|
|
Overall Study
Intent-to-treat (ITT) Population
|
61
|
57
|
|
Overall Study
COMPLETED
|
59
|
56
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
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. \[with Aliskiren 300 mg\]
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Abnormal laboratory values
|
0
|
2
|
|
Overall Study
Abnormal test procedure results
|
0
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
0
|
|
Overall Study
Protocol Deviation
|
3
|
2
|
|
Overall Study
Patient withdrew consent
|
5
|
2
|
Baseline Characteristics
Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren
Baseline characteristics by cohort
| Measure |
Diet Sequence Low/High Sodium
n=69 Participants
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
n=63 Participants
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
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
51.0 years
STANDARD_DEVIATION 7.16 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 7.75 • n=7 Participants
|
51.5 years
STANDARD_DEVIATION 7.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
MSSBP
|
147.6 mm Hg
STANDARD_DEVIATION 9.21 • n=5 Participants
|
146.2 mm Hg
STANDARD_DEVIATION 8.94 • n=7 Participants
|
146.9 mm Hg
STANDARD_DEVIATION 9.07 • n=5 Participants
|
|
MSDBP
|
92.7 mm Hg
STANDARD_DEVIATION 9.81 • n=5 Participants
|
93.6 mm Hg
STANDARD_DEVIATION 8.33 • n=7 Participants
|
93.1 mm Hg
STANDARD_DEVIATION 9.11 • n=5 Participants
|
|
MASBP
|
138.7 mm Hg
STANDARD_DEVIATION 8.30 • n=5 Participants
|
139.1 mm Hg
STANDARD_DEVIATION 8.52 • n=7 Participants
|
138.9 mm Hg
STANDARD_DEVIATION 8.38 • n=5 Participants
|
|
MADBP
|
86.6 mm Hg
STANDARD_DEVIATION 6.73 • n=5 Participants
|
87.7 mm Hg
STANDARD_DEVIATION 7.28 • n=7 Participants
|
87.1 mm Hg
STANDARD_DEVIATION 6.99 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4 and week 8 (4 weeks after crossover)Population: Completers Population: Included all patients who completed both diet periods - high and low sodium diets
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. \[At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MASBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).\]
Outcome measures
| Measure |
Low Sodium Diet
n=115 Participants
All patients who were on low sodium (\<= 100 mmol/day) diet
|
High Sodium Diet
n=115 Participants
All patients who were on high sodium (\>= 200 mmol/day) diet
|
|---|---|---|
|
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
Period 1 (4 weeks)
|
124.8 mm Hg
Standard Deviation 9.12
|
134.7 mm Hg
Standard Deviation 11.13
|
|
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
Period 2 (next 4 weeks after crossover)
|
123.6 mm Hg
Standard Deviation 11.69
|
132.5 mm Hg
Standard Deviation 10.07
|
SECONDARY outcome
Timeframe: Week 4 and week 8 (4 weeks after crossover)Population: Completers Population: Included all patients who completed both diet periods - high and low sodium diets
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. \[At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MADBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).\]
Outcome measures
| Measure |
Low Sodium Diet
n=115 Participants
All patients who were on low sodium (\<= 100 mmol/day) diet
|
High Sodium Diet
n=115 Participants
All patients who were on high sodium (\>= 200 mmol/day) diet
|
|---|---|---|
|
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
Period 1 (4 weeks)
|
78.5 mm Hg
Standard Deviation 7.37
|
85.0 mm Hg
Standard Deviation 9.06
|
|
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
Period 2 (next 4 weeks after crossover)
|
78.3 mm Hg
Standard Deviation 9.10
|
83.2 mm Hg
Standard Deviation 8.10
|
SECONDARY outcome
Timeframe: Week 4 and Week 8 (4 weeks after crossover)Population: Completers Population: Included all patients who completed both diet periods - high and low sodium diets
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. \[At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. Percent response for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).\]
Outcome measures
| Measure |
Low Sodium Diet
n=115 Participants
All patients who were on low sodium (\<= 100 mmol/day) diet
|
High Sodium Diet
n=115 Participants
All patients who were on high sodium (\>= 200 mmol/day) diet
|
|---|---|---|
|
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
Period 1 (4 weeks) - Response
|
78.0 Percentage of responders
|
41.1 Percentage of responders
|
|
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
Period 1 (4 weeks) - No response
|
20.3 Percentage of responders
|
58.9 Percentage of responders
|
|
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
Period 2 (next 4 weeks after crossover) - Response
|
75.0 Percentage of responders
|
44.1 Percentage of responders
|
|
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
Period 2 (next 4 wks after crossover) -No Response
|
25.0 Percentage of responders
|
55.9 Percentage of responders
|
Adverse Events
Low Sodium Diet
High Sodium Diet
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Sodium Diet
n=126 participants at risk
All patients who were on low sodium (\<= 100 mmol/day) diet.
|
High Sodium Diet
n=124 participants at risk
All patients who were on high sodium (\>= 200 mmol/day) diet.
|
|---|---|---|
|
Nervous system disorders
Headache
|
2.4%
3/126 • AE's in overall Safety Population (SP) after 8 weeks
Numbers in AE table are by overall diet, not diet sequence. AEs included overall Safety Population. Low Sodium Diet: 126=69 starters+57 after crossover (56 Completed + 1 who received medication but did not complete study); High Sodium Diet: 124=63 starters+61 after crossover (59 Completed + 2 who received medication but did not complete study)
|
6.5%
8/124 • AE's in overall Safety Population (SP) after 8 weeks
Numbers in AE table are by overall diet, not diet sequence. AEs included overall Safety Population. Low Sodium Diet: 126=69 starters+57 after crossover (56 Completed + 1 who received medication but did not complete study); High Sodium Diet: 124=63 starters+61 after crossover (59 Completed + 2 who received medication but did not complete study)
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER