Status:
COMPLETED
N-of-1 Trials In Children With Hypertension
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Pediatric Hypertension
Eligibility:
All Genders
10-22 years
Phase:
PHASE4
Brief 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 resear...
Detailed Description
Pediatric hypertension, a growing problem, often requires prescription of antihypertensive medication. Pediatric hypertension specialists lack an evidentiary base on which to establish definitive clin...
Eligibility Criteria
Inclusion
- 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
- age \< 10 years
- resistant hypertension (requiring ≥ 3 drug therapy)
- absolute contraindication or allergy to any of the tested drugs.
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03461003
Start Date
April 2 2018
End Date
May 2 2021
Last Update
September 9 2022
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030