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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00546052
First received: October 17, 2007
Last updated: November 22, 2013
Last verified: November 2013

October 17, 2007
November 22, 2013
September 2005
January 2008   (final data collection date for primary outcome measure)
  • Change in Hemoglobin A1c Between 52 Weeks and Baseline [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
    Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.
  • Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
    Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.
Levels of fasting glucose and HBA1C after one year of treatment [ Time Frame: 1 Year ]
Complete list of historical versions of study NCT00546052 on ClinicalTrials.gov Archive Site
  • Target Blood Pressure [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
    Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks
  • Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
    Absolute change in Systolic Blood Pressure between baseline and 52 week assessments.
  • Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
    Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments.
Not Provided
  • Change in Waist Circumference Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
    Absolute change in Waist Circumference between baseline and 52 week assessments
  • Change in Body Mass Index Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
    Absolute change in Body Mass Index Baseline and 52 week assessments
  • Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
    Percent Change in LDL-C Between Baseline and 52 week assessments: 100% x [(LDL-C 52 Weeks - LDL-C Baseline) / (LDL-C Baseline)].
  • Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
    Percent Change in HDL-C Between Baseline and 52 week assessments: 100% x [(HDL-C 52 Weeks - HDL-C 52 Baseline) / (HDL-C Baseline)].
  • Percent Change in Triglycerides Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
    Percent Change in Triglycerides Between Baseline and 52 week assessments: 100% x [(Triglycerides 52 Weeks - Triglycerides Baseline) / (Triglycerides Baseline)].
  • Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
    Percent Change in Total Cholesterol Between Baseline and 52 week assessments: 100% x [(Total Cholesterol 52 weeks - Total Cholesterol Baseline) / (Total Cholesterol Baseline)].
  • Absolute Change in Uric Acid Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
    Absolute Change in Uric Acid Between Baseline and 52 week assessments: Uric Acid 52 weeks - Uric Acid Baseline.
  • Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
    Absolute Change in C Reactive Protein Between Baseline and 52 week assessments: C Reactive Protein 52 weeks - C Reactive Protein Baseline.
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Metabolic Disorder
Drug: 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.
Other Name: Cozaar/Hyzaar
Experimental: 1
Losartan (MK0954) / Losartan + HCTZ (MK0954A)
Intervention: Drug: losartan potassium (+) hydrochlorothiazide
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1738
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00546052
0954-331, MK0954A-331, 2007_030
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP