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)
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: losartan potassium (+) hydrochlorothiazide; Comparator: Valsartan (+) Hydrochlorothiazide
Intervention description: losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide; Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide
Intervention MeSH terms: Losartan; Valsartan; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 808.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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.