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)

Tracking Information
First Submitted Date ICMJE	October 17, 2007
First Posted Date ICMJE	October 19, 2007
Results First Submitted Date	March 26, 2010
Results First Posted Date	April 13, 2010
Last Update Posted Date	May 5, 2017
Actual Study Start Date ICMJE	May 1, 2007
Actual Primary Completion Date	April 1, 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 26, 2010)	Change in Systolic Blood Pressure From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]; Change in Diastolic Blood Pressure From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
Original Primary Outcome Measures ICMJE; (submitted: October 17, 2007)	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 ]
Change History	Complete list of historical versions of study NCT00546754 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 20, 2010)	Change in Systolic Blood Pressure From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]; Change in Diastolic Blood Pressure From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]; Number of Patients Achieving Target Blood Pressure at Week 6 [ Time Frame: Week 6 ]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 ]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 ]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 ]; Change in Uric Acid From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]; Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]; Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]; Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6 [ Time Frame: Baseline and Week 6 ]; Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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)
Official Title ICMJE	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
Brief Summary	To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Hypertension
Intervention ICMJE	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
Study Arms	Experimental: 1 Drug Arm Intervention: Drug: losartan potassium (+) hydrochlorothiazide; Active Comparator: 2 active comparator Intervention: Drug: Comparator: Valsartan (+) Hydrochlorothiazide
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 26, 2010)	808
Original Estimated Enrollment ICMJE; (submitted: October 17, 2007)	1000
Actual Study Completion Date	May 1, 2009
Actual Primary Completion Date	April 1, 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	Canada
Administrative Information
NCT Number ICMJE	NCT00546754
Other Study ID Numbers ICMJE	0954A-333; MK0954A-333; 2007_031
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes 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
Responsible Party	Merck Sharp & Dohme Corp.
Study Sponsor ICMJE	Merck Sharp & Dohme Corp.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account	Merck Sharp & Dohme Corp.
Verification Date	March 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP