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
  Purpose

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


Condition
Hypertension

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 136
Study Start Date: September 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
  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: NCT01390415     History of Changes
Other Study ID Numbers: MK-0954-365
Study First Received: July 7, 2011
Results First Received: August 9, 2011
Last Updated: August 9, 2011
Health Authority: Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 14, 2014