Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren
A Randomized, Open-label, Blinded Endpoint, Multi-center, Cross-over Study to Evaluate the Effect of High and Low Sodium Diets on Reduction in Mean 24-hour Ambulatory Blood Pressure in Systolic Hypertensive Patients Treated With Aliskiren (300 mg)
1 other identifier
interventional
132
1 country
19
Brief Summary
This study will compare the effects of high and low level sodium (salt) diets on blood pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hypertension
Started Jan 2007
Shorter than P25 for phase_4 hypertension
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 26, 2007
CompletedFirst Posted
Study publicly available on registry
February 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
March 25, 2011
CompletedMarch 25, 2011
February 1, 2011
10 months
February 26, 2007
December 15, 2010
February 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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. \[At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MASBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).\]
Week 4 and week 8 (4 weeks after crossover)
Secondary Outcomes (2)
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
Week 4 and week 8 (4 weeks after crossover)
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
Week 4 and Week 8 (4 weeks after crossover)
Study Arms (2)
Diet Sequence Low/High Sodium
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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. \[with Aliskiren 300 mg\]
Interventions
Eligibility Criteria
You may qualify if:
- Male or female outpatients 18-60 years old
- Patients with systolic hypertension who met the 24 hour Ambulatory Blood Pressure Monitoring (ABPM) criteria (ABPM mean daytime Systolic Blood Pressure (SBP) \>= 135 mmHg and \< 160 mmHg)
You may not qualify if:
- Overt heart failure (HF) or a history of heart failure within preceding 6 months.
- Unstable angina pectoris.
- Type 1 or Type 2 diabetes mellitus or abnormal hemoglobin A1c(HbA1c)
- Body mass index (BMI) \> 30 kg/m2
- Subjects taking more than 2 antihypertensive medications.
- Use of other investigational drugs within 30 days of the time of enrollment
- Use of Tamsulosin hydrochloride and other alpha blockers.
- Use of Antiarrhythmic drugs, including digoxin.
- History of MI or cardiovascular attack (CVA) within the preceding 6 months.
- History of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin
- Pregnant or nursing (lactating) women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (19)
Novartis US
Orangevale, California, United States
Novartis US
Brooklyn Center, Minnesota, United States
Novartis US
Butte, Montana, United States
Novartis US
Missoula, Montana, United States
Novartis US
Lincoln, Nebraska, United States
Novartis US
Johnson City, New York, United States
Novartis US
Asheboro, North Carolina, United States
Novartis US
Shelby, North Carolina, United States
Novartis US
Cincinnati, Ohio, United States
Novartis US
Kettering, Ohio, United States
Novartis US
Downington, Pennsylvania, United States
Novartis US
Erie, Pennsylvania, United States
Novartis US
Pittsburgh, Pennsylvania, United States
Novartis US
Dallas, Texas, United States
Novartis US
Kingsport, Texas, United States
Novartis US
Bountiful, Utah, United States
Novartis US
Salt Lake City, Utah, United States
Novartis US
Port Orchard, Washington, United States
Novartis US
Madison, Wisconsin, United States
Related Publications (1)
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. doi: 10.1177/1074248410377173. Epub 2010 Sep 27.
PMID: 20876343RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY CHAIR
Novartis
Novartis
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 26, 2007
First Posted
February 28, 2007
Study Start
January 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
March 25, 2011
Results First Posted
March 25, 2011
Record last verified: 2011-02