Recruitment

Recruitment Status
Completed
Estimated Enrollment
112

Inclusion Criteria

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

Exclusion Criteria

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

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

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

Exclusion Criteria

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

Tracking Information

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