Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients

This study has been completed.

First Received on November 9, 2006. Last Updated on December 23, 2007 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00398541

Purpose

Evaluate the antihypertensive and neuroprotective effects of Hyzaar(R) in elderly subjects in comparison with Natrilix(TM).

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of the Antihypertensive Effect of Hyzaar(R) and Cognitive Function of Hypertensive Patients

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure Potassium

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

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Neuropsychological tests and blood pressure after treatment of 12 weeks [ Time Frame: after treatment of 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	41
Study Start Date:	March 2005
Study Completion Date:	June 2007

Intervention Details:

losartan potassium (+) hydrochlorothiazide combination will be titrated upwards according to the following scheme: losartan potassium 50/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 12.5 then losartan potassium 100/hydrochlorothiazide 25

Other Names:

MK954A
Hyzaar

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ACEi or ARB naive or not taking ACEi or ARB concurrently for at least one month before the run-in period
Be able to carry out his or her own daily activity
- Be at least 50 years old at inclusion in the study Be diagnosed with mild to moderate hypertension, treated or untreated
Literate
Not taking any cognitive-enhanced agent at baseline
Present with a memory complain ( spontaneous or informed by caregiver)

Exclusion Criteria:

Congestive heart failure with NYHA class >2
Renal failure or renal insufficiency with serum creatinine >1.4mg/dl
chronic severe liver disease with abnormal GPT and GOT >2 times of upper normal limits
Diagnosed with major depression when entering the study
Foreign language as his or her mother tongue so that the test results will not be reliable
History of stroke or transient ischemic attack (stroke is defined as focal neurological sign progressing stepwise)
Hypersensitive to the active ingredient and any other component of losartan potassium and indapamide tablets
Major hearing loss/deafness and/or major visual impairment/blindness preventing from performing the tests
Myocardial infarction within the past 6 months
Single functioning kidney
Anuria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398541

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00398541 History of Changes
Other Study ID Numbers:	2006_048, MK0954A-322
Study First Received:	November 9, 2006
Last Updated:	December 23, 2007
Health Authority:	Taiwan: National Bureau of Controlled Drugs

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Hydrochlorothiazide
Losartan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012