Center of Research Translation (CORT) Project 2
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 112
Inclusion Criteria
- Systolic blood pressure (SBP) ≥ 120 and <160 or;
- Diastolic blood pressure (DBP) ≥ 80 and < 100
- Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements:
- ...
- Systolic blood pressure (SBP) ≥ 120 and <160 or;
- Diastolic blood pressure (DBP) ≥ 80 and < 100
- Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements:
- Age 18-40
- Serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women
Exclusion Criteria
- Active smokers
- 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.
- ...
- Active smokers
- 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 gout or past use of urate-lowering therapy for gout
- Prior diagnosis of diabetes
- 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)
- Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype
- Leucopenia with absolute white cell count < 3000 /mL, anemia with hemoglobin < 12 g/dL, or thrombocytopenia with platelet count < 150,000/mL
- Estimated glomerular filtration rate < 60 mL/min/1.73m2
- Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months
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
- Systolic blood pressure (SBP) ≥ 120 and <160 or;
- Diastolic blood pressure (DBP) ≥ 80 and < 100
- Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements:
- ...
- Systolic blood pressure (SBP) ≥ 120 and <160 or;
- Diastolic blood pressure (DBP) ≥ 80 and < 100
- Pre-hypertension or stage I hypertension, defined as the following after the mean of two clinic measurements:
- Age 18-40
- Serum urate ≥ 5.0 mg/dL for men or ≥ 4.0 mg/dL for women
Exclusion Criteria
- Active smokers
- 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.
- ...
- Active smokers
- 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 gout or past use of urate-lowering therapy for gout
- Prior diagnosis of diabetes
- 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)
- Individuals of Han Chinese or Thai descent with HLAB5801 genetic phenotype
- Leucopenia with absolute white cell count < 3000 /mL, anemia with hemoglobin < 12 g/dL, or thrombocytopenia with platelet count < 150,000/mL
- Estimated glomerular filtration rate < 60 mL/min/1.73m2
- Pregnancy, or recent delivery or last trimester pregnancy loss more recent than 3 months
Tracking Information
- NCT #
- NCT02038179
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Investigators
- Not Provided
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