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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00739674
First received: August 20, 2008
Last updated: November 14, 2013
Last verified: November 2013

August 20, 2008
November 14, 2013
February 2008
July 2009   (final data collection date for primary outcome measure)
  • Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to Week 14 [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
Change in BP between the group with diet management and losartan based treatment versus a losartan based treatment only in hypertensive patients. [ Time Frame: 40 Week(s) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00739674 on ClinicalTrials.gov Archive Site
  • Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 40 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
  • Change in Systolic Blood Pressure From Baseline to Week 10 [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to Week 10 [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
  • Time to Achieve the Target Blood Pressure From Baseline [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).
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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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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)
  • 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.
    Intervention: Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [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.
    Interventions:
    • Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])
    • Behavioral: Low Salt Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
992
January 2010
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00739674
0954A-335, 2008_022, MK0954A-335
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP