Clinical trial 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Metabolic Disorder
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-10-18
Enrollment: 1738
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Hemoglobin A1c Between 52 Weeks and Baseline
timeFrame: 52 Weeks - Baseline
measure: Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments
timeFrame: 52 Weeks - Baseline
Secondary outcomes:
measure: Target Blood Pressure
timeFrame: 52 Weeks
measure: Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments
timeFrame: 52 Weeks - Baseline
measure: Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments
timeFrame: 52 Weeks - Baseline
Other outcomes:
measure: Change in Waist Circumference Between Baseline and 52 Week Assessments
timeFrame: 52 Weeks - Baseline
measure: Change in Body Mass Index Between Baseline and 52 Week Assessments
timeFrame: 52 Weeks - Baseline
measure: Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments
timeFrame: 52 Weeks - Baseline
measure: Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments
timeFrame: 52 Weeks - Baseline
measure: Percent Change in Triglycerides Between Baseline and 52 Week Assessments
timeFrame: 52 Weeks - Baseline
measure: Percent Change in Total Cholesterol Between Baseline and 52 Week Assessments
timeFrame: 52 Weeks - Baseline
measure: Absolute Change in Uric Acid Between Baseline and 52 Week Assessments
timeFrame: 52 Weeks - Baseline
measure: Absolute Change in C Reactive Protein Between Baseline and 52 Week Assessments
timeFrame: 52 Weeks - Baseline
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.