N-of-1 Trials In Children With Hypertension

PHASE4CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

April 2, 2018

Primary Completion Date

November 14, 2020

Study Completion Date

May 2, 2021

Conditions
Pediatric Hypertension
Interventions
OTHER

NICHE method

Based on underlying comorbidities at enrollment, patients will be assigned to either an unrestricted protocol (amlodipine versus lisinopril) or a restricted protocol (losartan versus lisinopril). Two drugs are tested in randomized order. Failure to achieve BP control at maximum doses of the first two drugs will result in augmentation with a diuretic (hydrochlorothiazide). BP control is assessed with 24 hour ambulatory monitoring at the end of each 2 week treatment period. Side effect tolerability is assessed with a questionnaire.

OTHER

Usual care

Physician preference will dictate choice and adjustment of antihypertensive medication, BP measurement modality, interval between visits, and assessment of side effects.

DRUG

Amlodipine

Calcium-channel blocker; antihypertensive

DRUG

Lisinopril

Angiotensin-converting-enzyme (ACE) inhibitor; antihypertensive

DRUG

Hydrochlorothiazide

Thiazide diuretic; antihypertensive

DRUG

Losartan

Angiotensin II receptor blocker (ARB); antihypertensive

Trial Locations (1)

77030

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

lead

The University of Texas Health Science Center, Houston

OTHER

NCT03461003 - N-of-1 Trials In Children With Hypertension | Biotech Hunter | Biotech Hunter