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)

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

NCT00546052•Organon and Co

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

September 1, 2005

Primary Completion Date

January 1, 2008

Completion Date

January 1, 2008

Last Updated

May 16, 2024

Enrollment

1,738

ACTUAL participants

Conditions

HypertensionMetabolic Disorder

Interventions

losartan potassium (+) hydrochlorothiazide

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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