Clinical trial NCT00441064: Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: High blood pressure, hypertension, aliskiren, low sodium diet
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-28
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Week 4 and week 8 (4 weeks after crossover)
Secondary outcomes:
measure: 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
timeFrame: Week 4 and week 8 (4 weeks after crossover)
measure: 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
timeFrame: Week 4 and Week 8 (4 weeks after crossover)
Other outcomes:
Locations:
city: Orangevale
country: United States
facility: Novartis US
state: California
city: Brooklyn Center
country: United States
facility: Novartis US
state: Minnesota
city: Butte
country: United States
facility: Novartis US
state: Montana
city: Missoula
country: United States
facility: Novartis US
state: Montana
city: Lincoln
country: United States
facility: Novartis US
state: Nebraska
city: Johnson City
country: United States
facility: Novartis US
state: New York
city: Asheboro
country: United States
facility: Novartis US
state: North Carolina
city: Shelby
country: United States
facility: Novartis US
state: North Carolina
city: Cincinnati
country: United States
facility: Novartis US
state: Ohio
city: Kettering
country: United States
facility: Novartis US
state: Ohio
city: Downington
country: United States
facility: Novartis US
state: Pennsylvania
city: Erie
country: United States
facility: Novartis US
state: Pennsylvania
city: Pittsburg
country: United States
facility: Novartis US
state: Pennsylvania
city: Dallas
country: United States
facility: Novartis US
state: Texas
city: Kingsport
country: United States
facility: Novartis US
state: Texas
city: Bountiful
country: United States
facility: Novartis US
state: Utah
city: Salt Lake City
country: United States
facility: Novartis US
state: Utah
city: Port Orchard
country: United States
facility: Novartis US
state: Washington
city: Madison
country: United States
facility: Novartis US
state: Wisconsin
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: 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.