A 52 Week Study to Evaluate the Effects of Losartan With or Without HCTZ on Plasma Glucose, Metabolic Parameters, Blood Pressure in Hypertensive Patients With Metabolic Syndrome

• Change in Hemoglobin A1c Between 52 Weeks and Baseline [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
  Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.
• Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
  Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.

• Target Blood Pressure [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks
• Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
  Absolute change in Systolic Blood Pressure between baseline and 52 week assessments.
• Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
  Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments.

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.

• Hypertension
• Metabolic Disorder

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