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) (EASE)

• Change in Systolic Blood Pressure From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
• Change in Diastolic Blood Pressure From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

• Change in Systolic Blood Pressure From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]
• Change in Diastolic Blood Pressure From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]
• Number of Patients Achieving Target Blood Pressure at Week 6 [ Time Frame: Week 6 ]
  Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 6
• Number of Patients Achieving Target Blood Pressure at Week 12 [ Time Frame: 12 Weeks ]
  Number of Patients Achieving Target Blood Pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics) at week 12
• Time to Achieve Target Blood Pressure [ Time Frame: 12 weeks ]
  Time to achieve the target blood pressure (<140/90 mmHg and <130/80 mmHg for diabetics)
• Change in Uric Acid From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]
• Change in Uric Acid From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
• Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]
• Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
• Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]
• Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]

• Drug: losartan potassium (+) hydrochlorothiazide
  losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide
• Drug: Comparator: Valsartan (+) Hydrochlorothiazide
  Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide

• Experimental: 1
  Drug Arm
  Intervention: Drug: losartan potassium (+) hydrochlorothiazide
• Active Comparator: 2
  active comparator
  Intervention: Drug: Comparator: Valsartan (+) Hydrochlorothiazide

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.

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

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