Status:
COMPLETED
Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00441064
Start Date
January 1 2007
End Date
November 1 2007
Last Update
March 25 2011
Active Locations (19)
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1
Novartis US
Orangevale, California, United States
2
Novartis US
Brooklyn Center, Minnesota, United States
3
Novartis US
Butte, Montana, United States
4
Novartis US
Missoula, Montana, United States