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OpenTrials
Completed

NCT Number: NCT00546052

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)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

losartan potassium (+) hydrochlorothiazide

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.

Other names: Cozaar/Hyzaar

Primary outcomes

  1. Change in Hemoglobin A1c Between 52 Weeks and Baseline

    Time frame: 52 Weeks - Baseline

    Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.

  2. Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments

    Time frame: 52 Weeks - Baseline

    Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.

Secondary outcomes

  1. Target Blood Pressure

    Time frame: 52 Weeks

    Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks

  2. Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments

    Time frame: 52 Weeks - Baseline

    Absolute change in Systolic Blood Pressure between baseline and 52 week assessments.

  3. Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments

    Time frame: 52 Weeks - Baseline

    Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments.

Other outcomes

  1. Change in Waist Circumference Between Baseline and 52 Week Assessments

    Time frame: 52 Weeks - Baseline

    Absolute change in Waist Circumference between baseline and 52 week assessments

  2. Change in Body Mass Index Between Baseline and 52 Week Assessments

    Time frame: 52 Weeks - Baseline

    Absolute change in Body Mass Index Baseline and 52 week assessments

  3. Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments

    Time frame: 52 Weeks - Baseline

    Percent Change in LDL-C Between Baseline and 52 week assessments: 100% x [(LDL-C 52 Weeks - LDL-C Baseline) / (LDL-C Baseline)].

  4. Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments

    Time frame: 52 Weeks - Baseline

    Percent Change in HDL-C Between Baseline and 52 week assessments: 100% x [(HDL-C 52 Weeks - HDL-C 52 Baseline) / (HDL-C Baseline)].

  5. Percent Change in Triglycerides Between Baseline and 52 Week Assessments

    Time frame: 52 Weeks - Baseline

    Percent Change in Triglycerides Between Baseline and 52 week assessments: 100% x [(Triglycerides 52 Weeks - Triglycerides Baseline) / (Triglycerides Baseline)].

  6. Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments

    Time frame: 52 Weeks - Baseline

    Percent Change in Total Cholesterol Between Baseline and 52 week assessments: 100% x [(Total Cholesterol 52 weeks - Total Cholesterol Baseline) / (Total Cholesterol Baseline)].

  7. Absolute Change in Uric Acid Between Baseline and 52 Week Assessments

    Time frame: 52 Weeks - Baseline

    Absolute Change in Uric Acid Between Baseline and 52 week assessments: Uric Acid 52 weeks - Uric Acid Baseline.

  8. Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments

    Time frame: 52 Weeks - Baseline

    Absolute Change in C Reactive Protein Between Baseline and 52 week assessments: C Reactive Protein 52 weeks - C Reactive Protein Baseline.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 18, 2007
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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