Study to Evaluate the Effectiveness of Diet Management With a Losartan Titration Regimen Versus Losartan Titration Regimen Alone on Blood Pressure Reduction in Hypertensives
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Losartan (Drug); hydrochlorothiazide (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in BP between the group with diet management and losartan based treatment versus a losartan based treatment only in hypertensive patients.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Michel Cimon, Phone: 514-428-2605
Additional Information
Starting date: January 2008
Last updated: January 8, 2009
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