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)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: losartan potassium (+) hydrochlorothiazide; Drug: Comparator: Valsartan (+) Hydrochlorothiazide

• Study Type: Interventional
• Enrollment (Actual): 808
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Systolic Blood Pressure From Baseline to Week 12	Baseline and Week 12
Change in Diastolic Blood Pressure From Baseline to Week 12	Baseline and Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2007
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: October 17, 2007
• First Submitted That Met QC Criteria: October 17, 2007
• First Posted (Estimate): October 19, 2007

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Valsartan; Losartan; Hydrochlorothiazide
• Other Study ID Numbers: 0954A-333; MK0954A-333; 2007_031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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

http://engagezone.msd.com/ds_documentation.php