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NCT03461003 · ClinicalTrials.gov registry record · Phase 4
N-of-1 Trials In Children With Hypertension
A Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 4
- Development phase
- 49
- Enrollment target
NCT03461003: Completed Phase 4 study, sponsored by The University of Texas Health Science Center, Houston.
NCT03461003 is a Phase 4 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 49 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03461003, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 49 participants
- Enrollment target
Study 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.
Primary Outcome
Blood pressure control is when ambulatory blood pressure is normal, with normal as defined by the American Heart Association (AHA) criteria \[the AHA criteria are systolic blood pressure and diastolic blood pressure (throughout wake and sleep) less than the 95th percentile based on the patient's gender and height\]. To assess ambulatory blood pressure, participants wear a 24-hour blood pressure monitor, which records blood pressure at regular intervals throughout a 24-hour period.
Interventions
- OTHER Usual care
- DRUG Amlodipine
- DRUG Lisinopril
- DRUG Hydrochlorothiazide
- OTHER NICHE method
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2018-04-02 |
| Est. Completion | 2021-05-02 |
| Phase | Phase 4 |
What the finished NCT03461003 record still lists
NCT03461003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which Usual care is the first listed.
NCT03461003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03461003 about?
NCT03461003 is a clinical study titled "N-of-1 Trials In Children With Hypertension". 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 ...
What is the current status of trial NCT03461003?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2018-04-02. Estimated completion is 2021-05-02.
What interventions are being tested in trial NCT03461003?
The interventions under investigation include: Usual care (OTHER), Amlodipine (DRUG), Lisinopril (DRUG), Hydrochlorothiazide (DRUG), NICHE method (OTHER).
Who is sponsoring clinical trial NCT03461003?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03461003's enrollment target sits among peer trials
49 1323rd of 2000 higher than 670 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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