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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Behavioral: Low Salt Diet; Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])

Study type: Interventional

Funder types: Industry

Identifiers

NCT00739674

MK0954A-335

0954A-335

2008_022

Details and patient eligibility

About

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.

Enrollment: 992 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non Diabetic, Newly Diagnosed And Untreated For Mild To Moderate Hypertension (blood pressure > 161; < 221; 140/90 mm Hg But < 180/110 mm Hg)
• Non diabetic, newly diagnosed and untreated for severe hypertension (blood pressure > 180/110 mm Hg but < 200/120 mm Hg); Patients who are asymptomatic with no evidence of significant end organ damage including direct pressure effects can be included. Patients in an urgency/emergency state are to be excluded
• Or Diabetic, Newly Diagnosed With Hypertension And Untreated With Mild To Moderate Hypertension (blood pressure > 161;< 221; 130/80 mm Hg But < 160/100 mm Hg); Or Patient Receiving One Antihypertensive Agent (Monotherapy Only) Used To Treat Hypertension For At Least 4 Weeks And Whose Blood Pressure Is Not Controlled: blood pressure > 161;< 221; 140/90 mm Hg But < 160/100 mm Hg Or For Diabetic And/Or Coronary Artery Disease Patients: blood pressure > 161;< 221; 130/80 mm Hg But > 161;< 221; 150/90 mm Hg
• The Antihypertensive Agent Will Need To Be Discontinued Prior To Starting Study Drug

Exclusion criteria

• Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Hypertensive Encephalopathy. Patient With Symptomatic Heart Failure (Classes 3 And 4). Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
• Patient Has Undergone Percutaneous Coronary Angioplasty, Has Had Coronary Artery Bypass Within The Last 6 Months Or Has Unstable Angina
• Patient With Anuria Or Confirmed Clinically Significant Renal Or Hepatic Dysfunction (Taken From Current/Past Medical Records) And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Ìmol/L Or Creatinine Clearance < 45 Ml/Min, Ast > 3 Times Above The Normal Range, Alt > 3 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
• Significant Liver Or Respiratory Disease, Cancer Or Other concomitant Disease That Is Likely To Affect Life Expectancy Of The Patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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992 participants in 2 patient groups

Losartan-Based Regimen Alone (L Group)

Active Comparator group

Description:

Losartan-based regimen, with sequential titration including HCTZ and CCB as needed to achieve target blood pressure.

Treatment:

Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])

Diet Management and Losartan-Based Regimen (DML Group)

Experimental group

Description:

Losartan with sequential titration including HCTZ and CCB as needed to achieve target blood pressure combined with low-salt intake diet.

Treatment:

Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])

Behavioral: Low Salt Diet