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)

Phase 3

Completed

• Conditions: Hypertension; Metabolic Disorder
• Interventions: Drug: losartan potassium (+) hydrochlorothiazide

• Registration Number: NCT00546052
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-01
• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-17
• Study First Posted: 2007-10-18
• Primary Completion: 2008-01-01
• Study Completion: 2008-01-01
• Results First Submitted: 2009-01-08
• Results First Submitted QC: 2009-05-04
• Results First Posted: 2009-06-23
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	losartan potassium (+) hydrochlorothiazide	Losartan (MK0954) / Losartan + HCTZ (MK0954A)

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c Between 52 Weeks and Baseline	52 Weeks - Baseline	Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.
Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments	52 Weeks - Baseline	Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.

Secondary Outcome Measures

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