BP-EASE -Effectiveness of Losartan 50 mg/HCTZ 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Hypertension Not Controlled on Monotherapy.

This study is ongoing, but not recruiting participants.

First Received: October 17, 2007 Last Updated: March 27, 2009 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00546754

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: losartan potassium (+) hydrochlorothiazide Drug: Comparator: Valsartan (+) Hydrochlorothiazide	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Losartan Losartan potassium Valsartan Potassium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	12-Week, Open-Label, Randomized, Controlled Trial Comparing the Effectiveness of Losartan 50 mg/HCTZ 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg in Hypertensives Not Controlled on Monotherapy.

Further study details as provided by Merck:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	850
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Drug Arm	Drug: losartan potassium (+) hydrochlorothiazide losartan potassium 50mg/12.5 Hydrochlorothiazide titrated as need to losartan potassium 100/25 mg Hydrochlorothiazide
2: Active Comparator active comparator	Drug: Comparator: Valsartan (+) Hydrochlorothiazide Valsartan 80/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160/25 mg Hydrochlorothiazide

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

An Adult Patient Between > 18 And 75 Years Of Age 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 Bp > 140/90 Mmhg Up To 160/100 Mmhg (Inclusive)
Either Systolic Or Diastolic Bp > 130/80 Mmhg Up To 150/90 Mmhg (Inclusive) For Diabetic Patients
Patient Is Male Or A Female Who Is Highly Unlikely To Conceive

Exclusion Criteria:

Patient Needing A Initiation Of A Lipid Lowering Agent Or A Modification Of His Lipid Therapy At Visit 1 Or During The Study Period (12 Weeks)
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, Ast > 2 Times Above The Normal Range, 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 Or With Chronic Inflammatory Conditions Such As Rheumatoid Arthritis, Lupus, Inflammatory Bowel Disease And Those That Needs A Chronic Inflammatory Therapy Such As Prednisone Or Other Steroid Agents
Patient With Symptomatic Heart Failure (Classes 3 And 4), With A History Of Stroke Within The Last 6 Months, Coronary Heart Disease: Has Undergone Percutaneous Coronary Angioplasty, Has Had Coronary Artery Bypass, Has Had Past Myocardial Infarction Or Has Angina

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546754

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_031, MK0954A-333
Study First Received:	October 17, 2007
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00546754 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Losartan
Sodium Chloride Symporter Inhibitors
Diuretics
Vascular Diseases
Anti-Arrhythmia Agents

Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Hydrochlorothiazide
Valsartan
Hypertension

Additional relevant MeSH terms:

Losartan
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Valsartan
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009