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.

Study Overview

• Status: Completed
• Conditions: Hypertension

• Study Type: Observational
• Enrollment (Actual): 136

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure (SBP)	SBP at baseline and month 6.	Baseline and Month 6
Diastolic Blood Pressure (DBP)	DBP at baseline and month 6.	Baseline and Month 6

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 11, 2011

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 0954-365