N/A
N=136
A Study to Evaluate Whether Losartan Protects the Kidney in Hypertensive Diabetic Participants With Microalbuminuria (MK0954-365 AM1)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01390415 ↗Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Sep 2011
Primary outcome: Primary: Number of Participants With Macroalbuminuria After 6 Months of Treatment — 7; 6 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Macroalbuminuria After 6 Months of Treatment |
7; 6 | — |
| SECONDARY Systolic Blood Pressure (SBP) |
149.5; 145.5; 136.9; 138.4; -14.0; -7.0 | 0.0374 sig |
| SECONDARY Diastolic Blood Pressure (DBP) |
85.6; 84.0; 78.2; 80.1; -9.3; -4.4 | 0.0566 |
Summary
This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria.
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
Data sourced from ClinicalTrials.gov (NCT01390415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.