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

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)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Aliskiren

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Orangevale, California, United States
      • Novartis US
  • Minnesota
    • Brooklyn Center, Minnesota, United States
      • Novartis US
  • Montana
    • Butte, Montana, United States
      • Novartis US
    • Missoula, Montana, United States
      • Novartis US
  • Nebraska
    • Lincoln, Nebraska, United States
      • Novartis US
  • New York
    • Johnson City, New York, United States
      • Novartis US
  • North Carolina
    • Asheboro, North Carolina, United States
      • Novartis US
    • Shelby, North Carolina, United States
      • Novartis US
  • Ohio
    • Cincinnati, Ohio, United States
      • Novartis US
    • Kettering, Ohio, United States
      • Novartis US
  • Pennsylvania
    • Downington, Pennsylvania, United States
      • Novartis US
    • Erie, Pennsylvania, United States
      • Novartis US
    • Pittsburg, Pennsylvania, United States
      • Novartis US
  • Texas
    • Dallas, Texas, United States
      • Novartis US
    • Kingsport, Texas, United States
      • Novartis US
  • Utah
    • Bountiful, Utah, United States
      • Novartis US
    • Salt Lake City, Utah, United States
      • Novartis US
  • Washington
    • Port Orchard, Washington, United States
      • Novartis US
  • Wisconsin
    • Madison, Wisconsin, United States
      • Novartis US

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet Sequence Low/High Sodium; 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]	Drug: Aliskiren
Experimental: Diet Sequence High/Low Sodium; 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]	Drug: Aliskiren

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The primary objective of the study was to assess 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. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MASBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]	Week 4 and week 8 (4 weeks after crossover)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	To evaluate the 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. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MADBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]	Week 4 and week 8 (4 weeks after crossover)
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	To evaluate the percentage of responders defined as MASBP < 130 mm Hg or a decrease in MASBP from baseline 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. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. Percent response for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]	Week 4 and Week 8 (4 weeks after crossover)

Collaborators and Investigators

• Sponsor: Novartis

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: February 26, 2007
• First Submitted That Met QC Criteria: February 27, 2007
• First Posted (Estimate): February 28, 2007

Study Record Updates

• Last Update Posted (Estimate): March 25, 2011
• Last Update Submitted That Met QC Criteria: February 28, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: High blood pressure, hypertension, aliskiren, low sodium diet
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CSPP100AUS02