Trial Outcomes & Findings for Febuxostat, Blood Pressure and the Intrarenal Renin-Angiotensin System (RAS) (NCT NCT01328769)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

49 participants

Primary outcome timeframe

Baseline to 6 weeks

Results posted on

2015-09-17

Participant Flow

Participant milestones

Participant milestones
Measure	Febuxostat 80mg once daily	Placebo Matching placebo dose 80mg once daily
Overall Study STARTED	25	24
Overall Study COMPLETED	25	23
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Febuxostat, Blood Pressure and the Intrarenal Renin-Angiotensin System (RAS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Febuxostat n=25 Participants 80mg daily	Placebo n=23 Participants Matching placebo dose 80mg once daily	Total n=48 Participants Total of all reporting groups
Age, Continuous	50.6 years STANDARD_DEVIATION 8.1 • n=39 Participants	48.6 years STANDARD_DEVIATION 8.0 • n=41 Participants	49.6 years STANDARD_DEVIATION 8.1 • n=35 Participants
Sex: Female, Male Female	4 Participants n=39 Participants	4 Participants n=41 Participants	8 Participants n=35 Participants
Sex: Female, Male Male	21 Participants n=39 Participants	19 Participants n=41 Participants	40 Participants n=35 Participants

PRIMARY outcome

Timeframe: Baseline to 6 weeks

Outcome measures

Outcome measures
Measure	Febuxostat n=25 Participants 80mg daily	Placebo n=23 Participants Matching placebo dose 80mg once daily
Change in Renal Plasma Flow in Response to Infused Angiotensin II	-54.1 ml/minute Standard Error 13.4	-10.8 ml/minute Standard Error 14

SECONDARY outcome

Timeframe: Baseline to 6 weeks

Endothelial function was calculated by software from the manufacturer VENDYS. The measurement was taken by using the index of area under the curve of the finger temperature recovery curve just after releasing a blood pressure cuff. The blood pressure cuff occluded blood flow for 5 minutes as compared to the temperature curve in the non-occluded arm.

Outcome measures

Outcome measures
Measure	Febuxostat n=18 Participants 80mg daily	Placebo n=18 Participants Matching placebo dose 80mg once daily
Change in Endothelial Function	1.66 ratio of finger temperature Standard Deviation 0.63	1.90 ratio of finger temperature Standard Deviation 0.39

Adverse Events

Febuxostat

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Paul Hopkins

University of Utah

Phone: 801-585-8139

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place