Phase 3 N=992 Randomized Treatment

SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00739674 ↗

Enrolled (actual)

992

Serious AEs

2.3%

Results posted

Aug 2010

Primary outcome: Primary: Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline — 276; 270; 116; 87 Participants — p=0.118

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]) (Drug); Low Salt Diet (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Jul 2009

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

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.

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

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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.