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

Completed

• Conditions: Hypertension

• Registration Number: NCT01390415
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Results First Submitted: 2011-08-09
• Results First Submitted QC: 2011-08-09
• Results First Posted: 2011-09-13
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure (SBP)	Baseline and Month 6	SBP at baseline and month 6.
Diastolic Blood Pressure (DBP)	Baseline and Month 6	DBP at baseline and month 6.