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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
This study has been completed.
First Received: October 17, 2007   Last Updated: June 29, 2009   History of Changes
Sponsor: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00546052
  Purpose

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.


Condition Intervention Phase
Hypertension
Metabolic Disorder
Drug: losartan potassium (+) hydrochlorothiazide
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:


Further study details as provided by Merck:

Primary Outcome Measures:
  • Change in Hemoglobin A1c Between 52 Weeks and Baseline [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
  • Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Target Blood Pressure [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
  • Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments [ Time Frame: 52 Weeks - Baseline ] [ Designated as safety issue: No ]

Enrollment: 1738
Study Start Date: September 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Losartan (MK0954) / Losartan + HCTZ (MK0954A)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546052

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
No publications provided

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2007_030, MK0954A-331
Study First Received: October 17, 2007
Results First Received: January 8, 2009
Last Updated: June 29, 2009
ClinicalTrials.gov Identifier: NCT00546052     History of Changes
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Losartan
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010