BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333)

Organon

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: losartan potassium (+) hydrochlorothiazide

Drug: Comparator: Valsartan (+) Hydrochlorothiazide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00546754

MK0954A-333

2007_031

0954A-333

Details and patient eligibility

About

To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.

Enrollment

808 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

An Adult Patient 18 to 75 Years Of Age
Patient with essential hypertension receiving an antihypertensive agent in monotherapy for at least 4 weeks for whom the antihypertensive agent can (and will) be discontinued and whose blood pressure is not controlled:
Either systolic or diastolic blood pressure > 140/90 mm Hg up to 180/110 mm Hg (inclusive)
Either systolic or diastolic blood pressure > 130/80 mm Hg up to 160/100 mm Hg (inclusive) for diabetic patients
Patient is male or a female who is highly unlikely to conceive as she falls into one of the categories listed below:
- Surgically sterilized female
- Postmenopausal female > 45 years of age with > 2 years since her last menses
- Non-sterilized pre-menopausal female who agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy [either 2 barrier methods or a barrier method plus a hormonal method]; or (2) abstain from heterosexual activity throughout the study starting with Visit 1 and for 14 days after the last dose of study medication; or (3) only engage in heterosexual activity with surgically sterilized male partner(s) throughout the study starting with Visit 1 and for 14 days after the last dose of study medication
- Patient judged to be in otherwise good, stable health on the basis of medical history and physical examination

Exclusion criteria

Known secondary hypertension of any aetiology (e.g., uncorrected renal artery stenosis, malignant hypertension, or hypertensive encephalopathy)
Patient Needing An Initiation Of A Lipid Lowering Agent Or A Modification Of His Lipid Therapy At Visit 1 Or During The Study Period (12 Weeks)
Patient taking allopurinol
Patient Previously Shown To Be Intolerant To Any Component Of Losartan Valsartan, Or HCTZ Or With A Documented History Of Angioedema/Anaphylaxis
Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Umol/L Or Creatinine Clearance < 45 Ml/Min, Aspartate transaminase (AST) > 2 Times Above The Normal Range, Alanine transaminase (ALT) > 2 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
Patient with osteoarthritis who has undergone hip or knee replacement within the last 4 months
Patient with chronic inflammatory conditions such as rheumatoid arthritis, lupus, inflammatory bowel disease and those that need a chronic inflammatory therapy such as prednisone or other steroid agents
Patient with symptomatic heart failure (classes 3 and 4)
Patient with a history of stroke within the last 6 months
Patient with coronary heart disease: has undergone percutaneous coronary angioplasty, has had coronary artery bypass, has had past myocardial infarction, all that occurred less than 6 months prior to visit 1 or has unstable angina
Patient having participated in an investigational drug program in the last 30 days (prior to Visit 1)
Unable or unwilling to comply with the protocol, therefore likely to leave the trial before its completion
Patient intends to move or to vacation away from home during the course of the study which would interfere with the scheduled visits.