Clinical trial NCT00739674: SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 992
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline
timeFrame: 14 Weeks
measure: Change in Systolic Blood Pressure From Baseline to Week 14
timeFrame: 14 Weeks
measure: Change in Diastolic Blood Pressure From Baseline to Week 14
timeFrame: 14 Weeks
Secondary outcomes:
measure: Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline
timeFrame: 6 Weeks
measure: Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline
timeFrame: 10 Weeks
measure: Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline
timeFrame: 40 Weeks
measure: Change in Systolic Blood Pressure From Baseline to Week 6
timeFrame: 6 Weeks
measure: Change in Diastolic Blood Pressure From Baseline to Week 6
timeFrame: 6 Weeks
measure: Change in Systolic Blood Pressure From Baseline to Week 10
timeFrame: 10 Weeks
measure: Change in Diastolic Blood Pressure From Baseline to Week 10
timeFrame: 10 Weeks
measure: Time to Achieve the Target Blood Pressure From Baseline
timeFrame: 14 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: