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)

Hypertension Clinical Trial

— EASE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546754
• Other study ID #: 0954A-333
• Secondary ID: MK0954A-3332007_
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2007
• Est. completion date: May 1, 2009

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 808
• Est. completion date: May 1, 2009
• Est. primary completion date: April 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• losartan potassium (+) hydrochlorothiazide
losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide
• Comparator: Valsartan (+) Hydrochlorothiazide
Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Systolic Blood Pressure From Baseline to Week 12		Baseline and Week 12
Primary	Change in Diastolic Blood Pressure From Baseline to Week 12		Baseline and Week 12
Secondary	Change in Systolic Blood Pressure From Baseline to Week 6		Baseline and Week 6
Secondary	Change in Diastolic Blood Pressure From Baseline to Week 6		Baseline and Week 6
Secondary	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
Secondary	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
Secondary	Time to Achieve Target Blood Pressure	Time to achieve the target blood pressure (<140/90 mmHg and <130/80 mmHg for diabetics)	12 weeks
Secondary	Change in Uric Acid From Baseline to Week 6		Baseline and Week 6
Secondary	Change in Uric Acid From Baseline to Week 12		Baseline and Week 12
Secondary	Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6		Baseline and Week 6
Secondary	Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12		Baseline and Week 12
Secondary	Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6		Baseline and Week 6
Secondary	Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12		Baseline and Week 12