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Center of Research Translation (CORT) Project 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02038179
Recruitment Status : Completed
First Posted : January 16, 2014
Results First Posted : February 26, 2020
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Kenneth Saag, MD, MSc, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Pre-hypertension
JNC 7 Stage I Hypertension
Interventions Drug: Allopurinol
Drug: Placebo
Enrollment 99
Recruitment Details  
Pre-assignment Details Participants completed a 2-4 week placebo run-in prior to assignment to study arm.
Arm/Group Title Allopurinol Then Placebo Placebo Then Allopurinol
Hide Arm/Group Description

Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.

The subjects will be randomized to receive allopurinol as urate lowering therapy (ULT), at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol (300 mg per day PO) or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol (300 mg per day PO) or placebo for an additional 4 weeks.

Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.

The subjects will be randomized to receive allopurinol as urate lowering therapy (ULT), at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol (300 mg per day PO) or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol (300 mg per day PO) or placebo for an additional 4 weeks.

Period Title: Phase 1 (4 Weeks)
Started 52 47
Completed 48 42
Not Completed 4 5
Period Title: Washout (2-4 Weeks)
Started 48 42
Completed 46 40
Not Completed 2 2
Period Title: Phase 2 (4 Weeks)
Started 46 40
Completed 44 38
Not Completed 2 2
Arm/Group Title Overall
Hide Arm/Group Description

Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.

Placebo: The subjects will be randomized to receive allopurinol as urate lowering therapy (ULT), at a daily dose of 300 mg once daily by mouth or placebo. Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.

Overall Number of Baseline Participants 99
Hide Baseline Analysis Population Description
Overall population baseline analytics are displayed. Data were collected prior to Phase 1 of the clinical trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants
28.0  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants
Female
37
  37.4%
Male
62
  62.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants
Hispanic or Latino
3
   3.0%
Not Hispanic or Latino
96
  97.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
40
  40.4%
White
52
  52.5%
More than one race
2
   2.0%
Unknown or Not Reported
2
   2.0%
Systolic Blood Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 99 participants
127  (11.3)
[1]
Measure Description: Systolic Blood Pressure collected via in-office sphygmomanometer. Report is the mean of 2 measurements.
Diastolic Blood Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 99 participants
81.3  (9.7)
[1]
Measure Description: Diastolic Blood Pressure collected via in-office sphygmomanometer. Report is the mean of 2 measurements.
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 99 participants
30.8  (7.7)
Serum urate (mg/dL)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 99 participants
5.8  (1.2)
Flow Mediated Dilation   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of dilation
Number Analyzed 96 participants
10.3  (5.2)
[1]
Measure Analysis Population Description: Not all participants successfully completed flow mediated dilation testing at baseline.
high sensitivity C-reactive protein (hs-CRP)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 96 participants
3.5  (4.5)
[1]
Measure Analysis Population Description: Not all participants had successful lab draws measuring highly sensitive C-reactive protein (hs-CRP) at baseline.
1.Primary Outcome
Title Change in Systolic Blood Pressure (SBP)
Hide Description Compare systolic blood pressure (SBP) captured by wearing a 24 hour ambulatory blood pressure monitor during each phase of treatment (allopurinol 300 mg/day PO or placebo). Change in systolic blood pressure is calculated by comparing SBP at the end of each treatment phase to pre-treatment values.
Time Frame 4 weeks (pre-treatment vs. post-treatment SBP)
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data was handled with a multiple imputations approach
Arm/Group Title Allopurinol Phase Placebo Phase
Hide Arm/Group Description:
Participants were evaluated for primary and secondary outcomes at visits pre- and post-treatment phase. During the phase participants received 300 mg, per day (PO) of allopurinol for approximately four weeks.
Participants were evaluated for primary and secondary outcomes at visits pre- and post-treatment phase. During the phase participants received placebo, daily (PO) for approximately four weeks.
Overall Number of Participants Analyzed 99 99
Mean (Standard Error)
Unit of Measure: mm Hg
-1.39  (10.0) -1.06  (8.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allopurinol Phase, Placebo Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments Intent-to-Treat Analysis using multiple imputation. Imputed Means and Imputed Standard Errors of the Mean.
Method paired t-test
Comments [Not Specified]
2.Primary Outcome
Title Change in Flow-mediated Arterial Vasodilation
Hide Description Compare endothelial function as indexed by flow-mediated arterial vasodilation (FMD) within each phase of treatment (allopurinol 300 mg/day PO or placebo). Percent (%) change in FMD is calculated by comparing FMD (%) at the end of each treatment phase to pre-treatment values.
Time Frame 4 weeks (pre-treatment vs. post-treatment FMD Values (%))
Hide Outcome Measure Data
Hide Analysis Population Description
Missing data was handled with a multiple imputation approach
Arm/Group Title Allopurinol Phase Placebo Phase
Hide Arm/Group Description:
Participants were evaluated for primary and secondary outcomes at visits pre- and post-treatment phase. During the phase participants received 300 mg, per day (PO) of allopurinol for approximately four weeks.
Participants were evaluated for primary and secondary outcomes at visits pre- and post-treatment phase. During the phase participants received placebo, daily (PO) for approximately four weeks.
Overall Number of Participants Analyzed 99 99
Mean (Standard Error)
Unit of Measure: percent change
2.5  (0.55) -0.1  (0.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allopurinol Phase, Placebo Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
3.Primary Outcome
Title Change in Serum Levels of High Sensitivity C-reactive Protein
Hide Description Serum level of high sensitivity C-reactive protein will be reported as a change during treatment phase (allopurinol 300 mg/day PO or placebo). Change in serum level of C-reactive protein is calculated by comparing serum values at the end of each treatment phase to pre-treatment levels.
Time Frame 4 weeks (pre-treatment vs. post-treatment serum levels)
Hide Outcome Measure Data
Hide Analysis Population Description
Data reported is imputed for missing.
Arm/Group Title Allopurinol Phase Placebo Phase
Hide Arm/Group Description:
Participants were evaluated for primary and secondary outcomes at visits pre- and post-treatment phase. During the phase participants received 300 mg, per day (PO) of allopurinol for approximately four weeks.
Participants were evaluated for primary and secondary outcomes at visits pre- and post-treatment phase. During the phase participants received placebo, daily (PO) for approximately four weeks.
Overall Number of Participants Analyzed 99 99
Mean (Standard Error)
Unit of Measure: mg/L
0.6  (0.39) 0.8  (0.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allopurinol Phase, Placebo Phase
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Time Frame Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
Adverse Event Reporting Description The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
 
Arm/Group Title Allopurinol Placebo
Hide Arm/Group Description

Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.

The subjects will be randomized to receive allopurinol as urate lowering therapy (ULT), at a daily dose of 300 mg once daily by mouth.

Participants will be asked to take 4 weeks of allopurinol or placebo, then will crossover to the other drug (after 2-4 week washout period) and take either allopurinol or placebo for an additional 4 weeks.

The subjects will be randomized to receive placebo once daily by mouth.

All-Cause Mortality
Allopurinol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/99 (0.00%)      0/99 (0.00%)    
Hide Serious Adverse Events
Allopurinol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/99 (0.00%)      0/99 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Allopurinol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/99 (12.12%)      12/99 (12.12%)    
Blood and lymphatic system disorders     
Leukopenia  [1]  0/99 (0.00%)  0 1/99 (1.01%)  2
Cardiac disorders     
Increase Blood Pressure (>= 160 disastolic blood pressure or >=90 systolic blood pressure) *  1/99 (1.01%)  1 0/99 (0.00%)  0
Tachycardia *  0/99 (0.00%)  0 1/99 (1.01%)  1
Ear and labyrinth disorders     
Dizziness *  0/99 (0.00%)  0 1/99 (1.01%)  1
Gastrointestinal disorders     
Diarrhea *  1/99 (1.01%)  1 2/99 (2.02%)  2
Hyper-defecation *  0/99 (0.00%)  0 1/99 (1.01%)  1
Nausea *  1/99 (1.01%)  1 3/99 (3.03%)  3
General disorders     
Fatigue *  3/99 (3.03%)  3 1/99 (1.01%)  1
Drowsiness *  1/99 (1.01%)  1 0/99 (0.00%)  0
Itch *  1/99 (1.01%)  1 1/99 (1.01%)  1
Weight Gain *  1/99 (1.01%)  1 0/99 (0.00%)  0
Hepatobiliary disorders     
Elevated Liver Enzyme   1/99 (1.01%)  1 0/99 (0.00%)  0
Nervous system disorders     
Headache *  1/99 (1.01%)  1 1/99 (1.01%)  1
Reproductive system and breast disorders     
Abnormal Menses *  1/99 (1.01%)  1 0/99 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Reduced white blood cell count
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Elizabeth Rahn
Organization: University of Alabama at Birmingham
Phone: 205-996-6552
EMail: elizabethrahn@uabmc.edu
Layout table for additonal information
Responsible Party: Kenneth Saag, MD, MSc, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02038179    
Other Study ID Numbers: F130408004
P50AR060772 ( U.S. NIH Grant/Contract )
First Submitted: December 20, 2013
First Posted: January 16, 2014
Results First Submitted: November 27, 2019
Results First Posted: February 26, 2020
Last Update Posted: March 17, 2020