Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00441064
First received: February 26, 2007
Last updated: February 28, 2011
Last verified: February 2011
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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:
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Aliskiren
U.S. FDA Resources
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
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 May 23, 2013