N-of-1 Trials In Children With Hypertension

• Status: Completed
• Trial end date: 2021-05-02
• Target enrollment: 0
• Participant gender: All

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. This trial will 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Amlodipine; Antihypertensive Agents; Hydrochlorothiazide; Lisinopril; Losartan

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.