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)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension, Metabolic Disorder

Intervention / Treatment
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* Drug: losartan potassium (+) hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Losartan (MK0954) / Losartan + HCTZ (MK0954A) | Drug: losartan potassium (+) hydrochlorothiazide<br>* 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.<br>* Other names: Cozaar/Hyzaar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c Between 52 Weeks and Baseline | Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value. | 52 Weeks - Baseline | 
| Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments | Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments. | 52 Weeks - Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Blood Pressure | Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks | 52 Weeks | 
| Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments | Absolute change in Systolic Blood Pressure between baseline and 52 week assessments. | 52 Weeks - Baseline | 
| Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments | Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments. | 52 Weeks - Baseline |