Official Title: “A 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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment : 1 Year
• Drug: MK0954, losartan potassium / Duration of Treatment : 1 Year

Primary Measures

• Levels of fasting glucose and HBA1C after one year of treatment
  • Time Frame: 1 Year
    

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 mmhg 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 mmhg but equal or less than 160/100 mmhg.
• or a patient whose hypertension is controlled (< 140/90mm 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00546052

Study ID Number: 2007_030

ClinicalTrials.gov Identifier: NCT00546052

Health Authority: Canada: Canadian Institutes of Health Research

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)