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Impact of MK-0954A on Uric Acid in the Management of Hypertension (MK-0954A-366)

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ClinicalTrials.gov Identifier: NCT01368185
Recruitment Status : Completed
First Posted : June 7, 2011
Results First Posted : September 1, 2011
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This was a retrospective, chart review, observational study to assess the effect of MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg [Hyzaar(R)]) treatment for a period of at least three months on serum uric acid levels.

Condition or disease
Hypertension

Study Design

Study Type : Observational
Actual Enrollment : 1705 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Survey to Evaluate the Impact of Hyzaar on Uric Acid in the Management of Hypertensive Patients in Normal Practice
Study Start Date : November 2008
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
Drug Information available for: Uric Acid
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
All Participants
Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months


Outcome Measures

Primary Outcome Measures :
  1. Serum Uric Acid (SUA) Level [ Time Frame: Baseline and Month 3 ]
    SUA at baseline and Month 3.


Secondary Outcome Measures :
  1. The Percentage of Patients With Hyperuricemia [ Time Frame: Baseline and Month 3 ]
    Hyperuricemia was defined as SUA >6.6mg/dL in females and >7.7mg/dL in males.

  2. Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and Month 3 ]
    DBP at baseline and month 3.

  3. Systolic Blood Pressure (SBP) [ Time Frame: Baseline and Month 3 ]
    SBP at baseline and month 3.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Data from 33 physicians from different levels of hospitals were invited to provide information on patients who received MK-0954A and had pre- and post-treatment serum uric acid and lipid profile reports during the study period. Each physician could provide up to 30 clinical charts of patients matching the inclusion criteria for the study.
Criteria

Inclusion criteria:

  • Participant was >20 years and <75 years of age on the index date (i.e., the date of initiating MK-0954A therapy)
  • Diagnosed with hypertension and had received MK-0954A 50/12.5 mg for at least 3 months
  • Had at least one serum uric acid measurements at baseline and one at 3 months after using MK-0954A 50/12.5 mg
  • Had the following records documented in the chart during the data collection period:

    • medical history and co-morbidities (if available)
    • sitting blood pressure, serum uric acid, lipid profile test results before and after using MK-0954A 50/12.5 mg
    • serum electrolytes, serum creatinine, and pre-meal sugar (if available)
    • prescription information of all antihypertensive regimens

Exclusion criteria:

  • Had been treated with diuretic or angiotensin-receptor blockers (ARBs) 2 weeks before initiated treatment with MK-0954A 50/12.5 mg
  • Serum creatinine >2 mg/dL
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01368185     History of Changes
Other Study ID Numbers: 0954A-366
MK-0954A-366
First Posted: June 7, 2011    Key Record Dates
Results First Posted: September 1, 2011
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Essential hypertension Uric acid Retrospective Hyzaar

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs