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

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.”

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.

Intervention(s) in this Clinical Trial

• 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)

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.

Primary Measures

• Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline
  • Time Frame: 14 Weeks
    Safety Issue?: No
• Change in Systolic Blood Pressure From Baseline to Week 14
  • Time Frame: 14 Weeks
    Safety Issue?: No
• Change in Diastolic Blood Pressure From Baseline to Week 14
  • Time Frame: 14 Weeks
    Safety Issue?: No

Secondary Measures

• Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline
  • Time Frame: 10 Weeks
    Safety Issue?: No
• Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline
  • Time Frame: 40 Weeks
    Safety Issue?: No
• Change in Systolic Blood Pressure From Baseline to Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Change in Diastolic Blood Pressure From Baseline to Week 6
  • Time Frame: 6 Weeks
    Safety Issue?: No
• Change in Systolic Blood Pressure From Baseline to Week 10
  • Time Frame: 10 Weeks
    Safety Issue?: No
• Change in Diastolic Blood Pressure From Baseline to Week 10
  • Time Frame: 10 Weeks
    Safety Issue?: No
• Time to Achieve the Target Blood Pressure From Baseline
  • Time Frame: 14 Weeks
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00739674

Study ID Number: MK0954A-335

ClinicalTrials.gov Identifier: NCT00739674

Health Authority: Canada: Health Canada

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Merck: Patient & Caregiver U.S. Product Web Site