drugset / Trial / NCT00568178
An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.
Timeline
- Start
- 2007-06-01
- Primary completion
- 2008-09-01
- Completion
- 2011-03-01
Outcome
Met primary endpoint
registry GEOMETRIC_MEAN Losartan: -35.80 (-43.11 to -27.55) Percent Change in Pr/Cr NCT00568178 ↗
registry analysis (unspecified test); Losartan vs Amlodipine/Placebo; p = 0.001; Ratio in Geometric Mean 0.63 (95% CI 0.54 to 0.74); Mixed Models Analysis NCT00568178 ↗
Publications
- Webb NJ, Shahinfar S, Wells TG, Massaad R, Gleim GW, McCrary Sisk C, Lam C. Losartan and enalapril are comparable in reducing proteinuria in children with Alport syndrome. Pediatr Nephrol. 2013 May;28(5):737-43. doi: 10.1007/s00467-012-2372-9. Epub 2012 Dec 4.
- Webb NJ, Shahinfar S, Wells TG, Massaad R, Gleim GW, Santoro EP, Sisk CM, Lam C. Losartan and enalapril are comparable in reducing proteinuria in children. Kidney Int. 2012 Oct;82(7):819-26. doi: 10.1038/ki.2012.210. Epub 2012 Jun 27.
- Webb NJ, Lam C, Shahinfar S, Strehlau J, Wells TG, Gleim GW, Le Bailly De Tilleghem C. Efficacy and safety of losartan in children with Alport syndrome--results from a subgroup analysis of a prospective, randomized, placebo- or amlodipine-controlled trial. Nephrol Dial Transplant. 2011 Aug;26(8):2521-6. doi: 10.1093/ndt/gfq797. Epub 2011 Feb 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Enalapril | Other / unclassified | 2.5 mg | Oral |
| Comparator | Enalapril | Other / unclassified | 5 mg | Oral |
| Comparator | Enalapril | Other / unclassified | 10 mg | Oral |
| Comparator | Enalapril | Other / unclassified | 20 mg | Oral |
| Subject | Losartan | Other / unclassified | 1.4 mg/kg | Oral |