LAAS (Losartan Anti-Atherosclerosis Study) - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00496834

Purpose

The primary objective of this study is to evaluate efficacy, arterial stiffness measured by PWV of Losartan potassium group compared to Carvedilol group after 24 weeks of treatment in patients with the essential hypertension.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-label, Comparative, Non-inferiority, Multicenter Study to Compare Efficacy of Losartan Potassium Group and Carvedilol Group on Arterial Stiffness in Essential Hypertension Patients

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

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

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Improvement of arterial stiffness [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Enrollment:	196
Study Start Date:	March 2008
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Losartan or Losartan/HCTZ	Drug: losartan potassium Losartan potassium 50 mg for 24 Weeks or Losartan potassium 100mg for 20 weeks Drug: Comparator: losartan (+) hydrochlorothiazide losartan (+) hydrochlorothiazide 100 mg/12.5 mg for 16 weeks or losartan (+) hydrochlorothiazide 100 mg/25 mg for 8 weeks
2: Active Comparator Carvedilol or Carvedilol/HCTZ	Drug: Comparator: carvedilol Carvedilol 12.5 mg for 24 Weeks or Carvedilol 25 mg for 20 weeks Drug: Comparator: carvedilol (+) hydrochlorothiazide Carvedilol (+) hydrochlorothiazide 25mg/12.5mg for 16 weeks or Carvedilol (+) hydrochlorothiazide 25 mg/25 mg for 8 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Male or Female adults, 18 years or over
Essential Hypertension with mean SBP>=140 mm Hg or mean DBP >= 90 mm Hg* when blood pressure is measured at Visit 1(week -2) and at Visit 2(week 0).

If diabetes patients, mean SBP >= 130 mm Hg or mean DBP >= 80 mm Hg (Mean of blood pressure values measured consecutively at least 2 minutes apart)

Patient who is willing to, and is able to sign the informed consent form

Exclusion Criteria:

Patient Is Pregnant Or Breastfeeding, Or Expecting To Conceive Within The Projected Duration Of The Study
Patient Has Known Or Suspected Secondary Hypertension Of Any Etiology
Patient has history of malignant hypertension
Patient has history of cerebrovascular accident (cerebral infarction) or myocardiac infarction within the last 6 months
Patient takes antihypertensive drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496834

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_015, MK0954-330
Study First Received:	July 3, 2007
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00496834 History of Changes
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Losartan
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension
Carvedilol

ClinicalTrials.gov processed this record on February 08, 2010