SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]); Low Salt Diet
Intervention description: Losartan 50 mg or 100 mg once daily for 40 weeks with sequential titration including HCTZ 12.5 mg or 25 mg and CCB only as needed to achieve target blood pressure, as follows:
Patients with mild-moderate hypertension, uncontrolled hypertension on monotherapy, or diabetes:
Losartan 50 mg
Losartan 100 mg
Losartan 100 mg/HCTZ 12.5 mg
Losartan 100 mg/HCTZ 25 mg
Losartan 100 mg/HCTZ 25 mg + CCB
Patients with severe hypertension:
Losartan 50 mg/HCTZ 12.5 mg
Losartan 100 mg/HCTZ 12.5 mg
Losartan 100 mg/HCTZ 25 mg
Losartan 100 mg/HCTZ 25 mg + CCB
Losartan 100 mg/HCTZ 25 mg + increasing CCB; Low-salt intake diet (Dietary Approaches to Stop Hypertension [DASH]) including:
Healthy diet
Reduction in sodium intake to less than 2300 mmol/day
Low alcohol consumption (less than 2 standard drinks/day)
Intervention MeSH terms: Losartan; Hydrochlorothiazide; Calcium Channel Blockers; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 992.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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; < 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