Study to Evaluate the Effectiveness of Diet Management With a Losartan Titration Regimen Versus Losartan Titration Regimen Alone on Blood Pressure Reduction in Hypertensives

This study is currently recruiting participants.

Verified by Merck, September 2009

First Received: August 20, 2008 Last Updated: September 2, 2009 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00739674

Purpose

To evaluate the effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients.

Condition	Intervention	Phase
Hypertension	Drug: Losartan Drug: hydrochlorothiazide	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Open-label Trial to Evaluate the Effectiveness of Diet Management With a Losartan Titration Regimen Versus Losartan Titration Regimen Alone on Blood Pressure Reduction in Hypertensives

Resource links provided by NLM:

MedlinePlus related topics: Diets High Blood Pressure

Drug Information available for: Hydrochlorothiazide Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change in BP between the group with diet management and losartan based treatment versus a losartan based treatment only in hypertensive patients. [ Time Frame: 40 Week(s) ] [ Designated as safety issue: No ]

Estimated Enrollment:	1700
Study Start Date:	January 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Arm 1: Drug & Diet	Drug: Losartan Losartan: Tablet, 50 mg titrated up to 100 mg; 40 week, daily. Drug: hydrochlorothiazide hydrochlorothiazide (HCTZ) 12.mg up to 25 mg + calcium channel blockers (CCB) as needed to achieve target BP goal , 40 week, daily.
2: Active Comparator Arm 2: Active Comparator	Drug: Losartan Losartan: Tablet, 50 mg titrated up to 100 mg; 40 week, daily. Drug: hydrochlorothiazide hydrochlorothiazide (HCTZ) 12.mg up to 25 mg + calcium channel blockers (CCB) as needed to achieve target BP goal , 40 week, daily.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Non Diabetic
Newly Diagnosed And Untreated For Mild To Moderate Hypertension (Bp > 161 < 221; 140/90 Mmhg But < 180/110 Mmhg)
Or Non Diabetic, Newly Diagnosed And Untreated For Severe Hypertension (Bp > 180/110 Mmhg But < 200/120 Mmhg)
Patients Who Are Asymptomatic With No Evidence Of Significant End Organ Damage Including Direct Pressure Effects Can Be Included
Patients In An Urgency/Emergency State Are To Be Excluded
Or Diabetic, Newly Diagnosed With Hypertension And Untreated With Mild To Moderate Hypertension (Bp > 161 < 221; 130/80 Mmhg But < 160/100 Mmhg); Or Patient Receiving One Antihypertensive Agent (Monotherapy Only) Used To Treat Hypertension For At Least 4 Weeks And Whose Blood Pressure Is Not Controlled: Bp > 161 < 221; 140/90 Mmhg But < 160/100 Mmhg Or For Diabetic And/Or Coronary Artery Disease Patients: Bp > 161 < 221; 130/80 Mmhg But Bp > 161 < 221; 150/90 Mmhg
The Antihypertensive Agent Will Need To Be Discontinued Prior To Starting Study Drug

Exclusion Criteria:

Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Hypertensive Encephalopathy
Patient With Symptomatic Heart Failure (Classes 3 And 4)
Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
Patient Has Undergone Percutaneous Coronary Angioplasty, Has Had Coronary Artery Bypass Within The Last 6 Months Or Has Unstable Angina
Patient With Anuria Or Confirmed Clinically Significant Renal Or Hepatic Dysfunction (Taken From Current/Past Medical Records) And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Ìmol/L Or Creatinine Clearance < 45 Ml/Min, Ast > 3 Times Above The Normal Range, Alt > 3 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
Significant Liver Or Respiratory Disease, Cancer Or Other concomitant Disease That Is Likely To Affect Life Expectancy Of The Patient

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739674

Locations

Canada, Quebec
Merck Frosst Canada Ltd.	Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Michel Cimon 514-428-2605

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_022, MK0954-335
Study First Received:	August 20, 2008
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00739674 History of Changes
Health Authority:	Canada: Canadian Institutes of Health Research

Study placed in the following topic categories:

Losartan
Diuretics
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents

Angiotensin II
Hydrochlorothiazide
Angiotensin II Type 1 Receptor Blockers
Calcium, Dietary
Anti-Arrhythmia Agents
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
Hypertension

ClinicalTrials.gov processed this record on September 11, 2009