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

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ClinicalTrials.gov Identifier: NCT01390415
Recruitment Status : Completed
First Posted : July 11, 2011
Results First Posted : September 13, 2011
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease
Hypertension

Study Type : Observational
Actual Enrollment : 136 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Survey to Evaluate the Renoprotective Effect of Losartan in Type II Diabetic Patients With Microalbuminuria and Hypertension in Real Life
Study Start Date : September 2008
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  1. Number of Participants With Macroalbuminuria After 6 Months of Treatment [ Time Frame: Baseline and Month 6 ]
    Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline.


Secondary Outcome Measures :
  1. Systolic Blood Pressure (SBP) [ Time Frame: Baseline and Month 6 ]
    SBP at baseline and month 6.

  2. Diastolic Blood Pressure (DBP) [ Time Frame: Baseline and Month 6 ]
    DBP at baseline and month 6.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01390415     History of Changes
Other Study ID Numbers: 0954-365
First Posted: July 11, 2011    Key Record Dates
Results First Posted: September 13, 2011
Last Update Posted: October 21, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action