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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441064

CSPP100AUS02

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

132 participants in 2 patient groups

Diet Sequence Low/High Sodium

Experimental group

Description:

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. \[with Aliskiren 300 mg\]

Treatment:

Drug: Aliskiren

Diet Sequence High/Low Sodium

Experimental group

Description:

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. \[with Aliskiren 300 mg\]

Treatment:

Drug: Aliskiren