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
Age 18-40
...
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
Age 18-40
Diastolic blood pressure (DBP) ≥ 80 and < 100
Systolic blood pressure (SBP) ≥ 120 and <160 or;

Exclusion Criteria

Serious medical condition that at investigator's judgment precludes utilization of a fixed dose of allopurinol
Immune-suppressed individuals including transplant recipients or current use of azathioprine.
Prior diagnosis of diabetes
...
Serious medical condition that at investigator's judgment precludes utilization of a fixed dose of allopurinol
Immune-suppressed individuals including transplant recipients or current use of azathioprine.
Prior diagnosis of diabetes
Estimated glomerular filtration rate < 60 mL/min/1.73m2
Active smokers
Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype
Current use of any urate-lowering therapy or statins
Any current pharmacological treatment for hypertension, including diuretics (calcium channel blockers at stable doses were later allowed)
Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months
Leucopenia with absolute white cell count < 3000 /mL, anemia with hemoglobin < 12 g/dL, or thrombocytopenia with platelet count < 150,000/mL
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
Age 18-40
...
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
Age 18-40
Diastolic blood pressure (DBP) ≥ 80 and < 100
Systolic blood pressure (SBP) ≥ 120 and <160 or;

Exclusion Criteria

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