N/A
N=35
Series of N-of-1 Crossover Trials of Antihypertensive Therapy in Adolescents With Essential Hypertension
Essential Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02412761 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: The Number of Patients for Whom Each Drug is Selected as the Preferred Therapy — 16; 8; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lisinopril (Drug); Amlodipine (Drug); Hydrochlorothiazide (Drug)
- Age
- Pediatric, Adult · 9+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients for Whom Each Drug is Selected as the Preferred Therapy |
16; 8; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of essential hypertension
- Treating physician has determined that pharmacologic therapy is necessary
Exclusion Criteria
- Compelling indication to select one particular medication
- Specific contraindication for any of the 3 therapies
Data sourced from ClinicalTrials.gov (NCT02412761). 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.