Official Title: “52 Week Study to Evaluate the Effects of LOSARTAN 50 mg, 100 mg, 100/12.5 mg HCTZ, 100/25 mg HCTZ on Metabolic Parameters, Blood Pressure and Safety in Hypertensive Patients With Metabolic Syndrome”

To determine if a one year treatment Losartan with or without HCTZ at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: losartan potassium (+) hydrochlorothiazide
  • All patients received Losartan 50mg at Visit 2 titrated to Losartan 100mg (if target BP not achieved) titrated to Losartan 100mg + HCTZ 12.5mg (if necessary) up to Losartan 100mg + HCTZ 25mg. Duration of treatment was one year.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Losartan (MK0954) / Losartan + HCTZ (MK0954A)

Primary Measures

• Change in Hemoglobin A1c Between 52 Weeks and Baseline
  • Time Frame: 52 Weeks - Baseline
    Safety Issue?: No
• Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments
  • Time Frame: 52 Weeks - Baseline
    Safety Issue?: No

Secondary Measures

• Target Blood Pressure
  • Time Frame: 52 Weeks
    Safety Issue?: No
• Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments
  • Time Frame: 52 Weeks - Baseline
    Safety Issue?: No
• Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments
  • Time Frame: 52 Weeks - Baseline
    Safety Issue?: No

Inclusion Criteria:

• An Adult Patient (At Least 18 Years Of Age) With A Clinical Identification Of The

Metabolic Syndrome Using The IDF Definition:

• abdominal (central) obesity as defined by the waist circumference in men of > 102 cm and women of > 88 cm or a BMI equal or greater than 30 kg/m2 and untreated hypertension with bp equal or greater than 140/90 mm Hg but bp < 180/110 mm Hg or a patient receiving one or two antihypertensive agent(s) (diuretics, ace inhibitors, angiotensin ii receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) and whose blood pressure is not controlled:
• bp equal or greater than 140/90 mm Hg but equal or less than 160/100 mm Hg or a patient whose hypertension is controlled (< 140/90 mm hg) with a single anti-hypertensive agent (diuretics, ace inhibitors, and angiotensin II receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) but who is unsatisfied or experiencing side effects warranting a discontinuation of the previous treatment and at one of the following:
• Fasting plasma glucose equal or greater than 5.6 mmol/L and < 7.0 mmol/L
• Triglycerides > 1.7 mmol/L or specific treatment for this lipid abnormality
• HDL-c in men < 0.9 mmol/L and in women < 1.1 mmol/L or specific treatment for this lipid abnormality

Exclusion Criteria:

• A Patient With A Diagnosis Of Type II Diabetes Defined As Fasting Blood Glucose Level
• Equal Or Greater Than 7.0 Mmol/L Or A 2hpg In A 75-G OGTT Equal Or Greater Than 11.1
• Mol/L Or Using Any Anti-Hyperglycemic Agents
• Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery
• Stenosis, Malignant Hypertension, Or Hypertensive Encephalopathy)
• Patient Intolerant To Any Component Of Losartan 50 Mg / Losartan 100 Mg / Losartan 100
• Mg + Hctz 12.5 Mg / Losartan 100 Mg + Hctz 25 Mg Or With A Documented History Of
• Angioedema
• Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or
• Electrolyte Imbalance On The Basis Of The Case History Or A Recent Laboratory Test (Serum Creatinine > 130 Mmol/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 Symptomatic Heart Failure (Classes 3 And 4)
• Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
• Patient Who Has Undergone Percutaneous Coronary Angioplasty Or Coronary Artery Bypass
• Within The Last 3 Months
• Pregnant Woman Or A Woman Of Childbearing Potential

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/NCT00546052

Study ID Number: 2007_030

ClinicalTrials.gov Identifier: NCT00546052

Health Authority: Canada: Health Canada

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