Series of N-of-1 Crossover Trials of Antihypertensive Therapy in Adolescents With Essential Hypertension



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:9 - 22
Updated:11/17/2018
Start Date:June 2013
End Date:July 2016

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Children are increasingly being diagnosed with essential hypertension and the absence of
comparative effectiveness research in antihypertensive therapies has contributed to
considerable differences in prescribing practices among physicians treating children with
essential hypertension.

This study will consist of a series of systematically-administered n-of-1 trials among
children to verify the need for ongoing antihypertensive treatment and if so, to identify the
preferred single drug therapy.

This is a series of systematically-administered n-of-1 trials among children with essential
hypertension to verify the need for ongoing antihypertensive treatment and if so, to identify
the preferred single drug therapy from among the three major classes of drugs commonly used
for essential hypertension (angiotensin converting enzyme inhibitors, calcium channel
blockers, and diuretics). The investigators will determine whether there is one that is
preferred for the great majority of patients. The "preferred" therapy will be defined as the
drug which produces normal ambulatory blood pressure, with the greatest reduction in awake
mean systolic blood pressure without unacceptable side effects.

For each patient, the order of the 3 drugs will be assigned randomly and each drug will be
taken for 2 weeks. The effectiveness of each drug will be measured with 24-hour ambulatory
blood pressure monitoring, and tolerability will be assessed using a side effect
questionnaire. Participants will rotate through treatment periods, repeating drugs and
adjusting doses until the preferred therapy is identified. In assessing whether one the
medications is most effective for the great majority of subjects, the primary outcome will be
the percentage of participants for whom each drug is selected as the preferred therapy.
Primary hypothesis: no drug will be selected for the majority of the subjects, a finding that
would support consideration of clinical use of n-of-1 trials. Secondary analyses will explore
whether patient characteristics predict which medication will be selected as a preferred
drug.

Inclusion Criteria:

- Clinical diagnosis of essential hypertension

- Treating physician has determined that pharmacologic therapy is necessary

Exclusion Criteria:

- Compelling indication to select one particular medication

- Specific contraindication for any of the 3 therapies
We found this trial at
1
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Houston, TX
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