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 BaselineChange in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments
Secondary outcome: Target Blood PressureChange 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
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