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

Phase 3

Completed

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

• Registration Number: NCT00739674
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-01
• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Primary Completion: 2009-07-01
• Study Completion: 2010-01-01
• Results First Submitted: 2010-07-14
• Results First Submitted QC: 2010-07-14
• Results First Posted: 2010-08-11
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 992

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet Management and Losartan-Based Regimen (DML Group)	Low Salt Diet	Losartan with sequential titration including HCTZ and CCB as needed to achieve target blood pressure combined with low-salt intake diet.
Diet Management and Losartan-Based Regimen (DML Group)	losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])	Losartan with sequential titration including HCTZ and CCB as needed to achieve target blood pressure combined with low-salt intake diet.
Losartan-Based Regimen Alone (L Group)	losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])	Losartan-based regimen, with sequential titration including HCTZ and CCB as needed to achieve target blood pressure.

Primary Outcome Measures

Name	Time	Method
Change in Diastolic Blood Pressure From Baseline to Week 14	14 Weeks
Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline	14 Weeks	Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment
Change in Systolic Blood Pressure From Baseline to Week 14	14 Weeks

Secondary Outcome Measures

Name	Time	Method
Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline	6 Weeks	Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment
Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline	10 Weeks	Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment
Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline	40 Weeks	Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment
Change in Systolic Blood Pressure From Baseline to Week 6	6 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 6	6 Weeks
Change in Systolic Blood Pressure From Baseline to Week 10	10 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 10	10 Weeks
Time to Achieve the Target Blood Pressure From Baseline	14 Weeks	Time to achieve the target blood pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics).