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

Organon

Status: Completed

Conditions: Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT01390415

0954-365

Details and patient eligibility

About

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

Enrollment: 136 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

136 participants in 2 patient groups

Losartan 50 mg

Description:

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

Description:

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.