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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis

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