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

NCT ID: NCT01390415

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-08-31

Brief Summary

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

Conditions

Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

0954-365

Identifier Type: -

Identifier Source: org_study_id