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

• ClinicalTrials.gov Identifier: NCT00739674
• Recruitment Status: Completed
• First Posted: August 22, 2008
• Results First Posted: August 11, 2010
• Last Update Posted: February 15, 2022
• Sponsor: Organon and Co
• Information provided by (Responsible Party): Organon and Co

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]); Behavioral: Low Salt Diet	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 992 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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.
• Actual Study Start Date: February 1, 2008
• Actual Primary Completion Date: July 1, 2009
• Actual Study Completion Date: January 1, 2010

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline [ Time Frame: 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
2. Change in Systolic Blood Pressure From Baseline to Week 14 [ Time Frame: 14 Weeks ]
3. Change in Diastolic Blood Pressure From Baseline to Week 14 [ Time Frame: 14 Weeks ]

Secondary Outcome Measures :

1. Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline [ Time Frame: 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
2. Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline [ Time Frame: 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
3. Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline [ Time Frame: 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
4. Change in Systolic Blood Pressure From Baseline to Week 6 [ Time Frame: 6 Weeks ]
5. Change in Diastolic Blood Pressure From Baseline to Week 6 [ Time Frame: 6 Weeks ]
6. Change in Systolic Blood Pressure From Baseline to Week 10 [ Time Frame: 10 Weeks ]
7. Change in Diastolic Blood Pressure From Baseline to Week 10 [ Time Frame: 10 Weeks ]
8. Time to Achieve the Target Blood Pressure From Baseline [ Time Frame: 14 Weeks ]
   Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Sponsors and Collaborators

Organon and Co

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

More Information

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00739674
• Other Study ID Numbers: 0954A-335; 2008_022; MK0954A-335
• First Posted: August 22, 2008
• Results First Posted: August 11, 2010
• Last Update Posted: February 15, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Losartan; Hydrochlorothiazide; Calcium Channel Blockers; Calcium; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Diuretics; Natriuretic Agents; Sodium Chloride Symporter Inhibitors; Membrane Transport Modulators