Status:
COMPLETED
SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)
Lead Sponsor:
Organon and Co
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
992 Patients enrolled
Trial Details
Trial ID
NCT00739674
Start Date
February 1 2008
End Date
January 1 2010
Last Update
May 16 2024
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