Uric Acid in Essential Hypertension in Children

NCT00288184 | Completed Phase 2

• 2 other identifiers: DK64587-DENA (completed)K23DK064587
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (2)

• Ambulatory BP

  three months

• Casual Blood Pressure

  three months

Secondary Outcomes (2)

• plasma renin activity

  three months

• Systemic vascular resistance

  three months

Study Arms (2)

Allopurinol

EXPERIMENTAL

Hypertensive children received both placebo and allopurinol in a cross over design.

Drug: Allopurinol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Allopurinol DRUG

Allopurinol adminsitered one 200mg capsule by mouth twice daily. Placebo capsule once daily during crossover

Allopurinol

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Baylor University: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Feig DI, Soletsky B, Johnson RJ. Effect of allopurinol on blood pressure of adolescents with newly diagnosed essential hypertension: a randomized trial. JAMA. 2008 Aug 27;300(8):924-32. doi: 10.1001/jama.300.8.924.

  PMID: 18728266 RESULT

MeSH Terms

Conditions

Essential Hypertension

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Daniel I. Feig, MD, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: September 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: August 1, 2007
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

US (1)