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)

NCT ID: NCT00546052

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1738 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-01
• Study Completion Date: 2008-01-01

Brief 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.

Conditions

Hypertension; Metabolic Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Losartan (MK0954) / Losartan + HCTZ (MK0954A)

Group Type: EXPERIMENTAL

losartan potassium (+) hydrochlorothiazide

Intervention Type: DRUG

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.

Interventions

losartan potassium (+) hydrochlorothiazide

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 Type: DRUG

Other Intervention Names

Cozaar/Hyzaar

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Racine N, Hamet P, Sampalis JS, Longo N, Bastien N. A 52-week prospective, cohort study of the effects of losartan with or without hydrochlorothiazide (HCTZ) in hypertensive patients with metabolic syndrome. J Hum Hypertens. 2010 Nov;24(11):739-48. doi: 10.1038/jhh.2010.3. Epub 2010 Feb 11.

Reference Type: RESULT

PMID: 20147971 (View on PubMed)

Other Identifiers

MK0954A-331

Identifier Type: -

Identifier Source: secondary_id

2007_030

Identifier Type: -

Identifier Source: secondary_id

0954A-331

Identifier Type: -

Identifier Source: org_study_id