Official Title: “12-Week, Open-Label, Randomized, Controlled Trial Comparing the Effectiveness of Losartan 50 mg/HCTZ 12.5 mg Versus Valsartan 80 mg/HCTz 12.5 mg in  Hypertensives Not Controlled on Monotherapy”

To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.

Study Type: Interventional

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

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: hydrochlorothiazide (+) losartan potassium
  • losartan potassium 50mg/12.5 mg Hydrochlorothiazide titrated as need to losartan potassium 100/25 mg Hydrochlorothiazide.
• Drug: Comparator: Valsartan (+) Hydrochlorothiazide
  • Valsartan 80/Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160/25 mg Hydrochlorothiazide.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Arm 1: Drug Arm
• Active Comparator: 2
  • Arm 2 : active comparator

Primary Measures

• Mean change reduction in SBP and DBP during 12 weeks of treatment with losartan 50 mg/HCTZ 12.5 mg titrated as needed versus valsartan 80 mg/HCTZ 12.5 mg titrated as needed
  • Time Frame: 12 Weeks
    Safety Issue?: No

Inclusion Criteria:

• An adult patient between > 18 and 75 years of age with essential hypertension receiving an antihypertensive agent in monotherapy for at least 4 weeks for whom the antihypertensive agent can (and will) be discontinued and whose blood pressure is not controlled:  
• either systolic or diastolic BP > 140/90 mmHg up to 160/100 mmHg (inclusive)
• either systolic or diastolic BP > 130/80 mmHg up to 150/90 mmHg (inclusive) for diabetic patients
• Patient is male or a female who is highly unlikely to conceive

Exclusion Criteria:

• Patient needing a initiation of a lipid lowering agent or a modification of his lipid therapy at visit 1 or during the study period (12 weeks)
• Patient previously shown to be intolerant to any component of losartan, valsartan, or hctz or with a documented history of angioedema/anaphylaxis
• Patient with confirmed clinically significant renal or hepatic dysfunction and/or electrolyte imbalance laboratory test within the last 3 months prior to visit 1: serum creatinine > 130 umol/L or creatinine clearance < 45 ml/min, AST >  2 times above the normal range, ALT > 2 times  above the normal range, serum potassium < 3.5 or > 5.5 meq/L
• Patient with osteoarthritis who has undergone hip or knee replacement within the last 4 months or with chronic inflammatory conditions such as rheumatoid arthritis, lupus, inflammatory bowel disease and those that needs a chronic inflammatory therapy such as prednisone or other steroid agents
• Patient with symptomatic heart failure (classes 3 and 4), with a history of stroke within the last 6 months, coronary heart disease: has undergone percutaneous coronary angioplasty, has had coronary artery bypass, has had past myocardial infarction or has angina

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

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 August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00546754

Study ID Number: 2007_031

ClinicalTrials.gov Identifier: NCT00546754

Health Authority: Canada: Canadian Institutes of Health Research

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)