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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: October 16, 2014
Last verified: October 2014

October 17, 2007
October 16, 2014
May 2007
April 2009   (final data collection date for primary outcome measure)
  • 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 ]
Mean change reduction in SBP and DBP during 12 weeks of treatment with losartan 50 mg/HCTZ 12.5 mg titrated as needed versus valsartan 80 mg/HCTZ 12.5 mg titrated as needed [ Time Frame: 12 Weeks ]
Complete list of historical versions of study NCT00546754 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
808
May 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00546754
0954A-333, MK0954A-333, 2007_031
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP