Status:
COMPLETED
Uric Acid in Essential Hypertension in Children
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
Baylor University
Conditions:
Essential Hypertension
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
Brief Summary
The study is a randomized, double-blinded, placebo controlled, crossover trial of allopurinol for the treatment of children with newly diagnosed essential hypertension.
Detailed Description
The study will be a double-blinded crossover trial. We will recruit 40 children between the ages of 12 and 18 years, from the pediatric renal and hypertension programs at Texas Children's Hospital. Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00288184
Start Date
September 1 2004
End Date
August 1 2007
Last Update
September 14 2017
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030