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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 (0954A-331)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Metabolic Disorder

Intervention: losartan potassium (+) hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change in Hemoglobin A1c Between 52 Weeks and Baseline

Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments

Secondary outcome:

Target Blood Pressure

Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments

Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments

Eligibility

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 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

Locations and Contacts

Additional Information

MedWatch - FDA maintained medical product safety Information

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

Starting date: September 2005
Last updated: June 23, 2015

Page last updated: August 23, 2015

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