Trial Outcomes & Findings for Center of Research Translation (CORT) Project 2 (NCT NCT02038179)
NCT ID: NCT02038179
Last Updated: 2021-01-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
99 participants
Primary outcome timeframe
4 weeks (pre-treatment vs. post-treatment SBP)
Results posted on
2021-01-11
Participant Flow
Participants completed a 2-4 week placebo run-in prior to assignment to study arm.
Participant milestones
| Measure |
Allopurinol Then Placebo
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.
|
Placebo Then Allopurinol
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.
|
|---|---|---|
|
Phase 1 (4 Weeks)
STARTED
|
52
|
47
|
|
Phase 1 (4 Weeks)
COMPLETED
|
48
|
42
|
|
Phase 1 (4 Weeks)
NOT COMPLETED
|
4
|
5
|
|
Washout (2-4 Weeks)
STARTED
|
48
|
42
|
|
Washout (2-4 Weeks)
COMPLETED
|
46
|
40
|
|
Washout (2-4 Weeks)
NOT COMPLETED
|
2
|
2
|
|
Phase 2 (4 Weeks)
STARTED
|
46
|
40
|
|
Phase 2 (4 Weeks)
COMPLETED
|
44
|
38
|
|
Phase 2 (4 Weeks)
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Not all participants successfully completed flow mediated dilation testing at baseline.
Baseline characteristics by cohort
| Measure |
Overall
n=99 Participants
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.
|
|---|---|
|
Age, Continuous
|
28.0 years
STANDARD_DEVIATION 7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Systolic Blood Pressure
|
127 mm Hg
STANDARD_DEVIATION 11.3 • n=99 Participants
|
|
Diastolic Blood Pressure
|
81.3 mm Hg
STANDARD_DEVIATION 9.7 • n=99 Participants
|
|
Body Mass Index
|
30.8 kg/m^2
STANDARD_DEVIATION 7.7 • n=99 Participants
|
|
Serum urate (mg/dL)
|
5.8 mg/dL
STANDARD_DEVIATION 1.2 • n=99 Participants
|
|
Flow Mediated Dilation
|
10.3 percentage of dilation
STANDARD_DEVIATION 5.2 • n=96 Participants • Not all participants successfully completed flow mediated dilation testing at baseline.
|
|
high sensitivity C-reactive protein (hs-CRP)
|
3.5 mg/L
STANDARD_DEVIATION 4.5 • n=96 Participants • Not all participants had successful lab draws measuring highly sensitive C-reactive protein (hs-CRP) at baseline.
|
PRIMARY outcome
Timeframe: 4 weeks (pre-treatment vs. post-treatment SBP)Population: Missing data was handled with a multiple imputations approach
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.
Outcome measures
| Measure |
Allopurinol Phase
n=99 Participants
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.
|
Placebo Phase
n=99 Participants
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.
|
|---|---|---|
|
Change in Systolic Blood Pressure (SBP)
|
-1.39 mm Hg
Standard Error 10.0
|
-1.06 mm Hg
Standard Error 8.94
|
PRIMARY outcome
Timeframe: 4 weeks (pre-treatment vs. post-treatment FMD Values (%))Population: Missing data was handled with a multiple imputation approach
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.
Outcome measures
| Measure |
Allopurinol Phase
n=99 Participants
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.
|
Placebo Phase
n=99 Participants
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.
|
|---|---|---|
|
Change in Flow-mediated Arterial Vasodilation
|
2.5 percent change
Standard Error 0.55
|
-0.1 percent change
Standard Error 0.42
|
PRIMARY outcome
Timeframe: 4 weeks (pre-treatment vs. post-treatment serum levels)Population: Data reported is imputed for missing.
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.
Outcome measures
| Measure |
Allopurinol Phase
n=99 Participants
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.
|
Placebo Phase
n=99 Participants
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.
|
|---|---|---|
|
Change in Serum Levels of High Sensitivity C-reactive Protein
|
0.6 mg/L
Standard Error 0.39
|
0.8 mg/L
Standard Error 0.82
|
Adverse Events
Allopurinol
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Allopurinol
n=99 participants at risk
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.
|
Placebo
n=99 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Increase Blood Pressure (>= 160 disastolic blood pressure or >=90 systolic blood pressure)
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
0.00%
0/99 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/99 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
Gastrointestinal disorders
Diarrhea
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
2.0%
2/99 • Number of events 2 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
Gastrointestinal disorders
Hyper-defecation
|
0.00%
0/99 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/99 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
Nervous system disorders
Headache
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
General disorders
Fatigue
|
3.0%
3/99 • Number of events 3 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
General disorders
Drowsiness
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
0.00%
0/99 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
General disorders
Itch
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
Reproductive system and breast disorders
Abnormal Menses
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
0.00%
0/99 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
General disorders
Weight Gain
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
0.00%
0/99 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/99 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
1.0%
1/99 • Number of events 2 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
Hepatobiliary disorders
Elevated Liver Enzyme
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
0.00%
0/99 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/99 • Number of events 1 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
3.0%
3/99 • Number of events 3 • Adverse events were collected for the duration of the study from date of enrollment to study completion (e.g., 12-14 weeks).
The definition of adverse event and/or serious adverse event is the same as clinicaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place