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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00441064
First received: February 26, 2007
Last updated: February 28, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Aliskiren
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 [ Time Frame: Week 4 and week 8 (4 weeks after crossover) ] [ Designated as safety issue: No ]
    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).]


Secondary Outcome Measures:
  • 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 [ Time Frame: Week 4 and week 8 (4 weeks after crossover) ] [ Designated as safety issue: No ]
    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).]

  • 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 [ Time Frame: Week 4 and Week 8 (4 weeks after crossover) ] [ Designated as safety issue: No ]
    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).]


Enrollment: 132
Study Start Date: January 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441064

Locations
United States, California
Novartis US
Orangevale, California, United States
United States, Minnesota
Novartis US
Brooklyn Center, Minnesota, United States
United States, Montana
Novartis US
Butte, Montana, United States
Novartis US
Missoula, Montana, United States
United States, Nebraska
Novartis US
Lincoln, Nebraska, United States
United States, New York
Novartis US
Johnson City, New York, United States
United States, North Carolina
Novartis US
Asheboro, North Carolina, United States
Novartis US
Shelby, North Carolina, United States
United States, Ohio
Novartis US
Cincinnati, Ohio, United States
Novartis US
Kettering, Ohio, United States
United States, Pennsylvania
Novartis US
Downington, Pennsylvania, United States
Novartis US
Erie, Pennsylvania, United States
Novartis US
Pittsburg, Pennsylvania, United States
United States, Texas
Novartis US
Dallas, Texas, United States
Novartis US
Kingsport, Texas, United States
United States, Utah
Novartis US
Bountiful, Utah, United States
Novartis US
Salt Lake City, Utah, United States
United States, Washington
Novartis US
Port Orchard, Washington, United States
United States, Wisconsin
Novartis US
Madison, Wisconsin, United States
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Publications:
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00441064     History of Changes
Other Study ID Numbers: CSPP100AUS02
Study First Received: February 26, 2007
Results First Received: December 15, 2010
Last Updated: February 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
High blood pressure, hypertension, aliskiren, low sodium diet

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014