Overview

Uric Acid in Essential Hypertension in Children

Status:
Completed

Trial end date:
2007-08-01

Target enrollment:
0

Participant gender:
All

Summary

The study is a randomized, double-blinded, placebo controlled, crossover trial of allopurinol for the treatment of children with newly diagnosed essential hypertension.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator:

Baylor University

Treatments:

Allopurinol

Criteria

Inclusion Criteria:

Males or females 12 to 18 years in age.

SBP or DBP greater than 95th percentile for age, gender and height

Diagnosis of primary hypertension after initial workup

No pharmacological therapy for hypertension in the past 12 months

Females must have a negative urine pregnancy test.

Parental or guardian consent and child subject assent

Exclusion Criteria:

Severe or poorly controlled hypertension as defined by SBP or DBP more than 20mmHg >95th
percentile for age, gender and height or a history of hypertensive encephalopathy

Identified cause of secondary hypertension Renal transplant

Taking a calcineurin inhibitor, azathioprine or another nucleoside analogue medication
(These medications have potentially serious drug interactions with Allopurinol.)

Currently receiving antihypertensive medication(s) or diuretic(s)

Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary or
renal disease (These abnormalities would be expected to alter drug metabolism and increase
the likelihood of medication side effects.):

Schwartz Formula GFR less than 60ml/min/1.73m2, AST/SGOT greater than 2 times the upper
limit of normal* ALT/SGPT greater than 2 times the upper limit of normal* Total or direct
bilirubin more than 2 times the upper limit of normal* Hemoglobin less than 9 gm/dl WBC
less than 3.000/mm3 Platelet count less than 100,000/mm3 *age-adjusted normal range