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)

Last updated: May 8, 2024
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

High Blood Pressure (Hypertension)

Vascular Diseases

Diabetes And Hypertension

Treatment

Comparator: Valsartan (+) Hydrochlorothiazide

losartan potassium (+) hydrochlorothiazide

Clinical Study ID

NCT00546754
0954A-333
2007_031
MK0954A-333
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • An Adult Patient 18 to 75 Years Of Age

  • Patient with essential hypertension receiving an antihypertensive agent inmonotherapy 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 oneof 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 methodsof contraception to prevent pregnancy [either 2 barrier methods or a barriermethod plus a hormonal method]; or (2) abstain from heterosexual activitythroughout the study starting with Visit 1 and for 14 days after the last doseof study medication; or (3) only engage in heterosexual activity withsurgically 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 medicalhistory and physical examination

Exclusion

Exclusion Criteria:

  • Known secondary hypertension of any aetiology (e.g., uncorrected renal arterystenosis, malignant hypertension, or hypertensive encephalopathy)

  • Patient Needing An Initiation Of A Lipid Lowering Agent Or A Modification Of HisLipid 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, OrHCTZ Or With A Documented History Of Angioedema/Anaphylaxis

  • Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/OrElectrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1:Serum Creatinine > 130 Umol/L Or Creatinine Clearance < 45 Ml/Min, Aspartatetransaminase (AST) > 2 Times Above The Normal Range, Alanine transaminase (ALT) > 2Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L

  • Patient with osteoarthritis who has undergone hip or knee replacement within thelast 4 months

  • Patient with chronic inflammatory conditions such as rheumatoid arthritis, lupus,inflammatory bowel disease and those that need a chronic inflammatory therapy suchas 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 coronaryangioplasty, has had coronary artery bypass, has had past myocardial infarction, allthat 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 trialbefore its completion

  • Patient intends to move or to vacation away from home during the course of the studywhich would interfere with the scheduled visits.

Study Design

Total Participants: 808
Treatment Group(s): 2
Primary Treatment: Comparator: Valsartan (+) Hydrochlorothiazide
Phase: 3
Study Start date:
May 01, 2007
Estimated Completion Date:
May 01, 2009