Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
NICHE: N-of-1 Approach in Children With Hypertension
NCT03461003Phase 4
Key facts
- Status
- Completed
- Start
- Apr 2018
- Primary completion
- Nov 2020
- Countries
- 1
- Sponsor
- UTHealth Houston
- Modality
- Small Molecules
- Conditions
- hypertension (HTN)
01
Overview
Phase 4, randomised, open-label trial of amlodipine, lisinopril, losartan and hydrochlorothiazide in hypertension (HTN) (2 arms), sponsored by UTHealth Houston. Primary endpoint: Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months. Started Apr 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
NICHE Method
Experimental arm using n-of-1 trials to identify optimal therapy.
Usual Care
Control arm receiving standard physician-led hypertension management.
03
Who it enrols
Children aged 10 and older with confirmed ambulatory hypertension requiring pharmacologic therapy, excluding those with resistant hypertension (requiring 3+ drugs).
04
Endpoints
Primary
Number of Participants With Ambulatory Blood Pressure (BP) Control at 6 Months
Secondary
Change in Mean 24-hour Ambulatory Systolic Blood Pressure
Change in Mean Wake Ambulatory Systolic Blood Pressure
Number of Participants Who Reported That Side Effects From Medication Led Them to Discontinue Medication
Number of Participants Who Self-reported Adherence to Intervention
Patient Satisfaction With Intervention as Assessed by a Survey
Beyond the preview
Go deeper on NCT03461003.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03461003.