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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00546754
First received: October 17, 2007
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: losartan potassium (+) hydrochlorothiazide
Drug: Comparator: Valsartan (+) Hydrochlorothiazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in Systolic Blood Pressure From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Systolic Blood Pressure From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Number of Patients Achieving Target Blood Pressure at Week 6 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in Uric Acid From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: No ]
  • Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Enrollment: 808
Study Start Date: May 2007
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug Arm
Drug: losartan potassium (+) hydrochlorothiazide
losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide
Active Comparator: 2
active comparator
Drug: Comparator: Valsartan (+) Hydrochlorothiazide
Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546754

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00546754     History of Changes
Other Study ID Numbers: 0954A-333, MK0954A-333, 2007_031
Study First Received: October 17, 2007
Results First Received: March 26, 2010
Last Updated: November 14, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Hydrochlorothiazide
Losartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 28, 2014