Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren

Completed · Phase 4

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00441064

Run by

Novartis

People needed

132

Starts

2007-01-01

Expected to finish

2007-11-01

Last updated by the study team

2011-03-25

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.