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

Randomized Open-label Trial to Evaluate the Effectiveness of Diet Management With a Losartan Titration Regimen Versus Losartan Titration Regimen Alone on Blood Pressure Reduction in Hypertensives.

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]); Behavioral: Low Salt Diet

• Study Type: Interventional
• Enrollment (Actual): 992
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Losartan-Based Regimen Alone (L Group); Losartan-based regimen, with sequential titration including HCTZ and CCB as needed to achieve target blood pressure.	Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]); 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
Experimental: Diet Management and Losartan-Based Regimen (DML Group); Losartan with sequential titration including HCTZ and CCB as needed to achieve target blood pressure combined with low-salt intake diet.	Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]); 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; Behavioral: Low Salt Diet; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline	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	14 Weeks
Change in Systolic Blood Pressure From Baseline to Week 14		14 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 14		14 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline	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	6 Weeks
Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline	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	10 Weeks
Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline	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	40 Weeks
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	Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).	14 Weeks

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: August 20, 2008
• First Submitted That Met QC Criteria: August 21, 2008
• First Posted (Estimate): August 22, 2008

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Calcium-Regulating Hormones and Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Calcium; Losartan; Hydrochlorothiazide; Calcium Channel Blockers
• Other Study ID Numbers: 0954A-335; 2008_022; MK0954A-335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php