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...
Date First Received: October 17, 2007
Last Updated: October 19, 2007
Verified by: Merck, October 2007
Clinical Trial Phase: Phase 4 | Start Date: September 2005
Overall Status: Completed
Estimated Enrollment: 1614
Brief Summary
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”
Condition Keyword(s):
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
Outcome Measures for this Clinical Trial
Primary Measures
- Levels of fasting glucose and HBA1C after one year of treatment
- Time Frame: 1 Year
- Time Frame: 1 Year
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
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)
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