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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014