Trial Outcomes & Findings for The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study (NCT NCT01701622)

Last Updated: 2018-01-12

Results Overview

The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

4 to 5 weeks

Results posted on

2018-01-12

Participant Flow

Recruitment - January 2010 - October 2011 Medical clinic

No significant events or approaches to report.

Participant milestones

Participant milestones
Measure	Allopurinol, Febuxostat Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared. febuxostat : If baseline allopurinol dose \< 300 mg daily, will initiate febuxostat 40 mg daily. If baseline allopurinol dose \> 300 mg daily, will initiate febuxostat 80 mg daily. Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Allopurinol, Febuxostat n=1 Participants Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared. febuxostat : If baseline allopurinol dose \< 300 mg daily, will initiate febuxostat 40 mg daily. If baseline allopurinol dose \> 300 mg daily, will initiate febuxostat 80 mg daily. Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	60 years n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants
Blood pressure Diastolic Blood Pressure	79 mm Hg n=93 Participants
Blood pressure Systolic Blood Pressure	131 mm Hg n=93 Participants

PRIMARY outcome

Timeframe: 4 to 5 weeks

Population: no analysis, as only one participant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for an expected average of 4 to 5 weeks.

measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.

Outcome measures

Outcome data not reported

Adverse Events

Febuxostat

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Debbie Minor

University of Mississippi Medical Center

Phone: 601-984-6888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place