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

0954A-331

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.

2005-09-01

2008-01-01

2008-01-01

Completed

Early phase I

1738

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1738, 'type': 'ACTUAL'}}

2024-05-16