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

Condition(s) targeted: Hypertension; Metabolic Disorder

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

Phase: Phase 4

Status: Completed

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

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.

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

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

Primary outcome: Levels of fasting glucose and HBA1C after one year of treatment

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 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

(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)

Starting date: September 2005
Ending date: December 2006
Last updated: October 19, 2007