Recruitment

Recruitment Status
Completed
Estimated Enrollment
112

Inclusion Criteria

Diastolic blood pressure (DBP) ≥ 80 and < 100
Systolic blood pressure (SBP) ≥ 120 and <160 or;
Age 18-40
...
Diastolic blood pressure (DBP) ≥ 80 and < 100
Systolic blood pressure (SBP) ≥ 120 and <160 or;
Age 18-40
Serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women
Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements:

Exclusion Criteria

Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype
Immune-suppressed individuals including transplant recipients or current use of azathioprine.
Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months
...
Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype
Immune-suppressed individuals including transplant recipients or current use of azathioprine.
Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months
Active smokers
Leucopenia with absolute white cell count < 3000 /mL, anemia with hemoglobin < 12 g/dL, or thrombocytopenia with platelet count < 150,000/mL
Any current pharmacological treatment for hypertension, including diuretics (calcium channel blockers at stable doses were later allowed)
Prior diagnosis of diabetes
Serious medical condition that at investigator's judgment precludes utilization of a fixed dose of allopurinol
Prior diagnosis of gout or past use of urate-lowering therapy for gout
Estimated glomerular filtration rate < 60 mL/min/1.73m2
Current use of any urate-lowering therapy or statins

Summary

Conditions
  • JNC 7 Stage I Hypertension
  • Pre Hypertension
  • Pre-Hypertension
Type
Interventional
Phase
Phase 2Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 40 years
Gender
Both males and females

Inclusion Criteria

Diastolic blood pressure (DBP) ≥ 80 and < 100
Systolic blood pressure (SBP) ≥ 120 and <160 or;
Age 18-40
...
Diastolic blood pressure (DBP) ≥ 80 and < 100
Systolic blood pressure (SBP) ≥ 120 and <160 or;
Age 18-40
Serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women
Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements:

Exclusion Criteria

Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype
Immune-suppressed individuals including transplant recipients or current use of azathioprine.
Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months
...
Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype
Immune-suppressed individuals including transplant recipients or current use of azathioprine.
Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months
Active smokers
Leucopenia with absolute white cell count < 3000 /mL, anemia with hemoglobin < 12 g/dL, or thrombocytopenia with platelet count < 150,000/mL
Any current pharmacological treatment for hypertension, including diuretics (calcium channel blockers at stable doses were later allowed)
Prior diagnosis of diabetes
Serious medical condition that at investigator's judgment precludes utilization of a fixed dose of allopurinol
Prior diagnosis of gout or past use of urate-lowering therapy for gout
Estimated glomerular filtration rate < 60 mL/min/1.73m2
Current use of any urate-lowering therapy or statins

Locations

Birmingham, Alabama, 35294
Birmingham, Alabama, 35294

Tracking Information

NCT #
NCT02038179
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Not Provided