Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren
NCT ID: NCT00441064
Last Updated: 2011-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
132 participants
INTERVENTIONAL
2007-01-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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. \[with Aliskiren 300 mg\]
Aliskiren
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. \[with Aliskiren 300 mg\]
Aliskiren
Interventions
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Aliskiren
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis
Role: STUDY_CHAIR
Novartis
Locations
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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
Countries
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References
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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.
Other Identifiers
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CSPP100AUS02
Identifier Type: -
Identifier Source: org_study_id
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