A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01390415
First received: July 7, 2011
Last updated: August 9, 2011
Last verified: August 2011

July 7, 2011
August 9, 2011
September 2008
August 2010   (final data collection date for primary outcome measure)
Number of Participants With Macroalbuminuria After 6 Months of Treatment [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline.
Number of participants with macroalbuminuria >300 mg/g and ≥30% increase in macroalbuminuria [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01390415 on ClinicalTrials.gov Archive Site
  • Systolic Blood Pressure (SBP) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    SBP at baseline and month 6.
  • Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    DBP at baseline and month 6.
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A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1)
A Retrospective Survey to Evaluate the Renoprotective Effect of Losartan in Type II Diabetic Patients With Microalbuminuria and Hypertension in Real Life

This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Adult participants with diabetes mellitus and hypertension treated with losartan 50 mg or 100 mg for at least 6 months in a hospital setting in Taiwan

Hypertension
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  • Losartan 50 mg
    Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
  • Losartan 100 mg
    Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diabetes mellitus
  • Hypertension and has received losartan 50 mg or losartan 100 mg for at least 6 months
  • Microalbuminuria (defined as microalbuminuria > 30 mg/g and < 300 mg/g by spot urine test)
  • Serum creatinine ≤1.5 mg/dL for men and ≤1.4mg/dL for women
  • Urinalysis with white blood cells (WBC) <5 cells per high power field
  • Results of hemoglobin A1c (HbA1c), fasting blood glucose, serum creatinine, urine albumin/urine creatinine ratio and urinary analysis tests at baseline and 6 months after initiating the losartan therapy are available
  • Medical history and co-morbidities (if available) listed in medical records
  • Prescription information of antihypertensive regimen of losartan 50 mg or 100 mg available

Exclusion criteria:

  • Treated with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB) before initiated treatment with losartan 50 mg or losartan 100 mg
  • Enrollment in another clinical trial
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01390415
MK-0954-365
No
Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP