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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: Losartan
  • Losartan: Tablet, 50 mg titrated up to 100 mg; 40 week, daily.
• Drug: hydrochlorothiazide
  • hydrochlorothiazide (HCTZ) 12.mg up to 25 mg + calcium channel blockers (CCB) as needed to achieve target BP goal , 40 week, daily.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Arm 1: Drug & Diet
• Active Comparator: 2
  • Arm 2: Active Comparator

Primary Measures

• 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)
    Safety Issue?: No

Inclusion Criteria:

• Non Diabetic
• Newly Diagnosed And Untreated For Mild To Moderate Hypertension (Bp > 161 < 221;
• 140/90 Mmhg But < 180/110 Mmhg)
• Or Non Diabetic, Newly Diagnosed And Untreated For Severe Hypertension (Bp > 180/110
• Mmhg But < 200/120 Mmhg)
• 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 (Bp > 161 < 221; 130/80 Mmhg But < 160/100 Mmhg); Or Patient Receiving
• One Antihypertensive Agent (Monotherapy Only) Used To Treat Hypertension For At Least 4 Weeks And Whose Blood Pressure Is Not Controlled: Bp > 161 < 221; 140/90 Mmhg But <
• 160/100 Mmhg Or For Diabetic And/Or Coronary Artery Disease Patients: Bp > 161 < 221;
• 130/80 Mmhg But Bp > 161 < 221; 150/90 Mmhg
• 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 Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on July 02, 2009

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

Study ID Number: 2008_022

ClinicalTrials.gov Identifier: NCT00739674

Health Authority: Canada: Canadian Institutes of Health Research