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.

Sponsors

Lead Sponsor: Merck Sharp & Dohme Corp.

Source Merck Sharp & Dohme Corp.
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.

Overall Status Completed
Start Date February 1, 2008
Completion Date January 1, 2010
Primary Completion Date July 1, 2009
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline 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
Measure Time Frame
Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline 6 Weeks
Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline 10 Weeks
Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline 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 14 Weeks
Enrollment 992
Condition
Intervention

Intervention Type: Drug

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

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

Intervention Type: Behavioral

Intervention Name: Low Salt Diet

Description: 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)

Arm Group Label: Diet Management and Losartan-Based Regimen (DML Group)

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Medical Monitor Study Director Merck Sharp & Dohme Corp.
Verification Date

March 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Losartan-Based Regimen Alone (L Group)

Type: Active Comparator

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

Label: Diet Management and Losartan-Based Regimen (DML Group)

Type: Experimental

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

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov