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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01368185
First received: June 6, 2011
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  Purpose

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
Hypertension

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Uric Acid
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Serum Uric Acid (SUA) Level [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    SUA at baseline and Month 3.


Secondary Outcome Measures:
  • The Percentage of Patients With Hyperuricemia [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    Hyperuricemia was defined as SUA >6.6mg/dL in females and >7.7mg/dL in males.

  • Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    DBP at baseline and month 3.

  • Systolic Blood Pressure (SBP) [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    SBP at baseline and month 3.


Enrollment: 1705
Study Start Date: November 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01368185     History of Changes
Other Study ID Numbers: MK-0954A-366
Study First Received: June 6, 2011
Results First Received: August 2, 2011
Last Updated: August 2, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Merck:
Essential hypertension Uric acid Retrospective Hyzaar

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

ClinicalTrials.gov processed this record on June 13, 2013