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)

NCT00546754 | Completed Phase 3 Results

• 3 other identifiers: 0954A-333MK0954A-3332007_031
• Study Type: interventional
• Target: 808
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

  Week 6

• Number of Patients Achieving Target Blood Pressure at Week 12

  12 Weeks

• Time to Achieve Target Blood Pressure

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug Arm

Drug: losartan potassium (+) hydrochlorothiazide

2

ACTIVE COMPARATOR

active comparator

Drug: Comparator: Valsartan (+) Hydrochlorothiazide

Interventions

losartan potassium (+) hydrochlorothiazide DRUG

losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide

1

Comparator: Valsartan (+) Hydrochlorothiazide DRUG

Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Hypertension

Interventions

hydrochlorothiazide, losartan drug combination; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 19, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 16, 2024
• Results First Posted: April 13, 2010

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share