drugset / Trial / NCT02412761
Series of N-of-1 Crossover Trials of Antihypertensive Therapy in Adolescents With Essential Hypertension
RandomizedCrossoverSingle-blindTreatment
Summary
Children are increasingly being diagnosed with essential hypertension and the absence of comparative effectiveness research in antihypertensive therapies has contributed to considerable differences in prescribing practices among physicians treating children with essential hypertension. This study will consist of a series of systematically-administered n-of-1 trials among children to verify the need for ongoing antihypertensive treatment and if so, to identify the preferred single drug therapy.
Timeline
- Start
- 2013-06
- Primary completion
- 2016-07
- Completion
- 2016-07
Publications
- Background Samuel JP, Samuels JA, Brooks LE, Bell CS, Pedroza C, Molony DA, Tyson JE. Comparative effectiveness of antihypertensive treatment for older children with primary hypertension: study protocol for a series of n-of-1 randomized trials. Trials. 2016 Jan 8;17:16. doi: 10.1186/s13063-015-1142-y.
- Samuel JP, Tyson JE, Green C, Bell CS, Pedroza C, Molony D, Samuels J. Treating Hypertension in Children With n-of-1 Trials. Pediatrics. 2019 Apr;143(4):e20181818. doi: 10.1542/peds.2018-1818. Epub 2019 Mar 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amlodipine | Other / unclassified | 10 mg | Oral |
| Comparator | Hydrochlorothiazide | Unknown | 3 mg/kg | Oral |
| Comparator | Hydrochlorothiazide | Unknown | 50 mg | Oral |
| Comparator | LISINOPRIL ANHYDROUS | Small molecule | 0.6 mg/kg | Oral |
| Comparator | LISINOPRIL ANHYDROUS | Small molecule | 40 mg | Oral |