Phase 3
Completed N=992
SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)
Source: ClinicalTrials.gov NCT00739674 ↗Enrolled (actual)
992
Serious AEs
2.3%
Results posted
Aug 2010
Primary outcomePrimary: Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline — 276; 270; 116; 87 Participants — p=0.118
Summary
To evaluate the effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline |
276; 270; 116; 87 | 0.118 |
| PRIMARY Change in Systolic Blood Pressure From Baseline to Week 14 |
-21.01; -22.74 | 0.507 |
| PRIMARY Change in Diastolic Blood Pressure From Baseline to Week 14 |
-10.19; -12.05 | 0.058 |
| SECONDARY Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline |
239; 231; 192; 152 | 0.092 |
| SECONDARY Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline |
257; 254; 142; 116 | 0.122 |
| SECONDARY Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline |
264; 240; 87; 91 | 0.434 |
| SECONDARY Change in Systolic Blood Pressure From Baseline to Week 6 |
-16.81; -18.85 | 0.158 |
| SECONDARY Change in Diastolic Blood Pressure From Baseline to Week 6 |
-8.34; -9.76 | 0.064 |
| SECONDARY Change in Systolic Blood Pressure From Baseline to Week 10 |
-19.11; -20.95 | 0.262 |
| SECONDARY Change in Diastolic Blood Pressure From Baseline to Week 10 |
-9.48; -11.42 | 0.026 sig |
| SECONDARY Time to Achieve the Target Blood Pressure From Baseline |
7.43; 6.57 | 0.212 |
Eligibility Criteria
Inclusion Criteria
- Non Diabetic, Newly Diagnosed And Untreated For Mild To Moderate Hypertension (blood pressure > 161; 180/110 mm Hg but 161; 161; 161; 161; 130 Ìmol/L Or Creatinine Clearance 3 Times Above The Normal Range, Alt > 3 Times Above The Normal Range, Serum Potassium 5.5 Meq/L
- Significant Liver Or Respiratory Disease, Cancer Or Other concomitant Disease That Is Likely To Affect Life Expectancy Of The Patient
Data sourced from ClinicalTrials.gov (NCT00739674). 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. Informational only — not medical advice.