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

February 26, 2007
February 28, 2011
January 2007
November 2007   (final data collection date for primary outcome measure)
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).]
Change from baseline in mean 24-hour ambulatory systolic blood pressure on aliskiren 300mg for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet
Complete list of historical versions of study NCT00441064 on ClinicalTrials.gov Archive Site
  • 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).]
  • Change in mean 24-hour ambulatory diastolic blood pressure on aliskiren 300 mg for 4 weeks on a high sodium diet versus 4 wks on a low sodium diet.
  • Responder rate defined as a drop in systolic blood pressure (SBP) of 20 mmHg or a mean 24-hour ambulatory SBP of < 130 mmHg from baseline on aliskiren 300 mg for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet.
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Drug: Aliskiren
  • 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]
    Intervention: 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]
    Intervention: Drug: Aliskiren
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. Epub 2010 Sep 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
November 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00441064
CSPP100AUS02
No
External Affairs, Novartis
Novartis
Not Provided
Study Chair: Novartis Novartis
Novartis
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP