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 (0954A-331)
Condition: Hypertension; Metabolic Disorder
MeSH terms: Metabolic Syndrome; Metabolic Diseases
Intervention: losartan potassium (+) hydrochlorothiazide
Intervention description: 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.
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1738.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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