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

Official Title: “BP-EASE-A 12-Week, Multicenter, Open-Label, Randomized, Controlled Trial To Compare The Effectiveness of Losartan 50 mg/HCTZ 12.5 mg Titrated as Needed to Losartan 100 mg/HCTZ 25 mg or Valsartan 160 mg/HCTZ 25 mg, in Patients With Essential Hypertension Who Have Not Achieved Target Blood Pressure With”

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

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Drug Arm
• Active Comparator: 2
  • active comparator

Primary Measures

• Change in Systolic Blood Pressure From Baseline to Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Change in Diastolic Blood Pressure From Baseline to Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No

Secondary Measures

• Change in Systolic Blood Pressure From Baseline to Week 6
  • Time Frame: Baseline and Week 6
    Safety Issue?: No
• Change in Diastolic Blood Pressure From Baseline to Week 6
  • Time Frame: Baseline and Week 6
    Safety Issue?: No
• Number of Patients Achieving Target Blood Pressure at Week 6
  • Time Frame: Week 6
    Safety Issue?: No
• Number of Patients Achieving Target Blood Pressure at Week 12
  • Time Frame: 12 Weeks
    Safety Issue?: No
• Time to Achieve Target Blood Pressure
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change in Uric Acid From Baseline to Week 6
  • Time Frame: Baseline and Week 6
    Safety Issue?: No
• Change in Uric Acid From Baseline to Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6
  • Time Frame: Baseline and Week 6
    Safety Issue?: No
• Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6
  • Time Frame: Baseline and Week 6
    Safety Issue?: No
• Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12
  • Time Frame: Baseline and Week 12
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00546754

Study ID Number: 2007_031

ClinicalTrials.gov Identifier: NCT00546754

Health Authority: Canada: Health Canada

MedWatch - FDA maintained medical product safety Information

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