Trial Outcomes & Findings for Effect of Febuxostat on Blood Pressure (NCT NCT01496469)
NCT ID: NCT01496469
Last Updated: 2015-08-31
Results Overview
The change in 24-hour mean SBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2015-08-31
Participant Flow
Participants took part at 29 sites in the United States from 10 January 2012 to 04 August 2014.
Participants with a historical diagnosis of hypertension along with hyperuricemia were enrolled in 1 of 2 treatment groups as follows: Placebo; Febuxostat 80 milligram (mg).
Participant milestones
| Measure |
Placebo
Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
|
Febuxostat 80 mg
Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
|
Overall Study
COMPLETED
|
50
|
53
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
|
Febuxostat 80 mg
Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
BP exceeds protocol limits
|
1
|
2
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
Effect of Febuxostat on Blood Pressure
Baseline characteristics by cohort
| Measure |
Placebo
n=60 Participants
Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
|
Febuxostat 80 mg
n=61 Participants
Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.08 years
STANDARD_DEVIATION 10.607 • n=5 Participants
|
52.15 years
STANDARD_DEVIATION 10.469 • n=7 Participants
|
53.60 years
STANDARD_DEVIATION 10.597 • n=5 Participants
|
|
Age, Customized
Less than (<) 45 years
|
8 participants
n=5 Participants
|
14 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Age, Customized
45 - <65 years
|
44 participants
n=5 Participants
|
43 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Age, Customized
Greater than or equal to (>=) 65 years
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
42 participants
n=5 Participants
|
41 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 participants
n=5 Participants
|
14 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
51 participants
n=5 Participants
|
47 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
61 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Height
|
172.10 centimeter (cm)
STANDARD_DEVIATION 8.564 • n=5 Participants
|
173.33 centimeter (cm)
STANDARD_DEVIATION 9.206 • n=7 Participants
|
172.72 centimeter (cm)
STANDARD_DEVIATION 8.878 • n=5 Participants
|
|
Weight
|
95.35 kilogram (kg)
STANDARD_DEVIATION 21.199 • n=5 Participants
|
100.88 kilogram (kg)
STANDARD_DEVIATION 19.490 • n=7 Participants
|
98.14 kilogram (kg)
STANDARD_DEVIATION 20.460 • n=5 Participants
|
|
Body Mass Index (BMI)
|
31.99 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.133 • n=5 Participants
|
33.55 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.913 • n=7 Participants
|
32.78 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 5.572 • n=5 Participants
|
|
BMI Category
18.5 - <25
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
BMI Category
25 - <30
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
BMI Category
>=30
|
39 participants
n=5 Participants
|
41 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Smoking History
Never smoked
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Smoking History
Current smoker
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Smoking History
Ex-smoker
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Alcohol History
Never Drunk
|
26 participants
n=5 Participants
|
20 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Alcohol History
Current Drinker
|
32 participants
n=5 Participants
|
37 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Alcohol History
Ex-Drinker
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Renal Function
Moderately Impaired
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Renal Function
Mildly Impaired
|
33 participants
n=5 Participants
|
30 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Renal Function
Normal
|
19 participants
n=5 Participants
|
26 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Baseline serum uric acid (sUA)
< 8.0 milligram per deciliter (mg/dL)
|
40 participants
n=5 Participants
|
47 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Baseline serum uric acid (sUA)
>=8.0 mg/dL
|
20 participants
n=5 Participants
|
14 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Baseline Medication
ARB or ACEi
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Baseline Medication
None
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.
The change in 24-hour mean SBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Outcome measures
| Measure |
Placebo
n=53 Participants
Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
|
Febuxostat 80 mg
n=56 Participants
Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
|
|---|---|---|
|
Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6
Baseline
|
142.3 millimeters of mercury (mmHg)
Standard Error 1.21
|
139.5 millimeters of mercury (mmHg)
Standard Error 1.18
|
|
Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6
Change at Week 6
|
-3.4 millimeters of mercury (mmHg)
Standard Error 1.31
|
-3.7 millimeters of mercury (mmHg)
Standard Error 1.27
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.
The change in 24-hour mean DBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Outcome measures
| Measure |
Placebo
n=53 Participants
Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
|
Febuxostat 80 mg
n=56 Participants
Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
|
|---|---|---|
|
Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6
Baseline
|
85.9 mmHg
Standard Error 1.14
|
83.0 mmHg
Standard Error 1.11
|
|
Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6
Change at Week 6
|
-2.7 mmHg
Standard Error 0.91
|
-2.0 mmHg
Standard Error 0.88
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.
Outcome measures
| Measure |
Placebo
n=52 Participants
Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
|
Febuxostat 80 mg
n=51 Participants
Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
|
|---|---|---|
|
Change From Baseline in Serum Urate Levels at Week 6
Change at Week 6
|
0.1 mg/dL
Standard Error 0.17
|
-3.3 mg/dL
Standard Error 0.17
|
|
Change From Baseline in Serum Urate Levels at Week 6
Baseline
|
7.7 mg/dL
Standard Error 0.14
|
7.6 mg/dL
Standard Error 0.14
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Febuxostat 80 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=60 participants at risk
Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
|
Febuxostat 80 mg
n=61 participants at risk
Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
|
|---|---|---|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/60 • Treatment-emergent AEs are defined as any AEs, regardless of relationship to study drug, which occurs on or after the first double-blind dose date and up to 30 days after the last dose date of the double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.6%
1/61 • Treatment-emergent AEs are defined as any AEs, regardless of relationship to study drug, which occurs on or after the first double-blind dose date and up to 30 days after the last dose date of the double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood pressure increased
|
1.7%
1/60 • Treatment-emergent AEs are defined as any AEs, regardless of relationship to study drug, which occurs on or after the first double-blind dose date and up to 30 days after the last dose date of the double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/61 • Treatment-emergent AEs are defined as any AEs, regardless of relationship to study drug, which occurs on or after the first double-blind dose date and up to 30 days after the last dose date of the double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=60 participants at risk
Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
|
Febuxostat 80 mg
n=61 participants at risk
Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.7%
1/60 • Treatment-emergent AEs are defined as any AEs, regardless of relationship to study drug, which occurs on or after the first double-blind dose date and up to 30 days after the last dose date of the double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.9%
3/61 • Treatment-emergent AEs are defined as any AEs, regardless of relationship to study drug, which occurs on or after the first double-blind dose date and up to 30 days after the last dose date of the double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER