Phase 4
Completed N=49
N-of-1 Trials In Children With Hypertension
Pediatric Hypertension
Source: ClinicalTrials.gov NCT03461003 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months — 8; 8; 10; 15 Participants
◆ Published Evidence
Emerging
9citations · ~3 / year
N-of-1 Trials vs. Usual Care in Children With Hypertension: A Pilot Randomized Clinical Trial.
Summary
The single patient (n-of-1) randomized trial is an underused approach to resolving therapeutic uncertainty by using a patient's own data to inform an individualized treatment plan. The proposed research is designed to assess whether the n-of-1 trial approach improves blood pressure control compared to usual care. This trial aims to advance learning about not only the treatment of pediatric hypertension but also the use of a neglected type of randomized trial to optimize the care of each patient.
Linked Publications
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N-of-1 Trials vs. Usual Care in Children With Hypertension: A Pilot Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months |
8; 8; 10; 15 | — |
| SECONDARY Change in Mean 24-hour Ambulatory Systolic Blood Pressure |
-10.6; -5.1 | — |
| SECONDARY Change in Mean Wake Ambulatory Systolic Blood Pressure |
-10.5; -6.2 | — |
| SECONDARY Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication |
0; 3 | — |
| SECONDARY Number of Participants Who Self-reported Adherence to Intervention |
5; 6 | — |
| SECONDARY Patient Satisfaction With Intervention as Assessed by a Survey |
9.929; 9.667 | — |
Eligibility Criteria
Inclusion Criteria
- treating physician determines that pharmacologic therapy is indicated for treatment of hypertension
- ambulatory hypertension has been confirmed (off meds) within 12 months of enrollment
Exclusion Criteria
- age < 10 years
- resistant hypertension (requiring ≥ 3 drug therapy)
- absolute contraindication or allergy to any of the tested drugs.
Data sourced from ClinicalTrials.gov (NCT03461003) and the linked publication. 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. Informational only — not medical advice.