Uric Acid in Essential Hypertension in Children
Completed · Phase 2 · Has a placebo group
Conditions studied: Essential Hypertension
In brief
The study is a randomized, double-blinded, placebo controlled, crossover trial of allopurinol for the treatment of children with newly diagnosed essential hypertension.
Key facts
- Study ID
- NCT00288184
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 30
- Starts
- 2004-09-01
- Expected to finish
- 2007-08-01
- Last updated by the study team
- 2017-09-14
Who can join
Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Texas Children's Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.