Phase 4
N=132
Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00441064 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: 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 — 124.8; 134.7; 123.6; 132.5 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aliskiren (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Nov 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
124.8; 134.7; 123.6; 132.5 | — |
| SECONDARY 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 |
78.5; 85.0; 78.3; 83.2 | — |
| SECONDARY 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 |
78.0; 41.1; 20.3; 58.9; 75.0; 44.1 | — |
Summary
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00441064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.