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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00398541
First received: November 9, 2006
Last updated: December 23, 2007
Last verified: December 2007
History of Changes
  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 3

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:

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:
    Drug: losartan potassium (+) hydrochlorothiazide
    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 May 16, 2013