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Effect of Febuxostat on Blood Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01496469
First received: December 18, 2011
Last updated: July 31, 2015
Last verified: July 2015
Results First Received: July 31, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Febuxostat
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part at 29 sites in the United States from 10 January 2012 to 04 August 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Placebo   Febuxostat 80 mg
STARTED   60   61 
COMPLETED   50   53 
NOT COMPLETED   10   8 
Adverse Event                1                0 
Protocol Violation                2                0 
Lost to Follow-up                1                1 
Withdrawal by Subject                4                4 
BP exceeds protocol limits                1                2 
Other                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Placebo   Febuxostat 80 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   61   121 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.08  (10.607)   52.15  (10.469)   53.60  (10.597) 
Age, Customized 
[Units: Participants]
     
Less than (<) 45 years   8   14   22 
45 - <65 years   44   43   87 
Greater than or equal to (>=) 65 years   8   4   12 
Gender 
[Units: Participants]
     
Female   12   11   23 
Male   48   50   98 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   0   1   1 
Asian   7   8   15 
Black or African American   11   10   21 
White   42   41   83 
More than one race   0   1   1 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino   9   14   23 
Not Hispanic or Latino   51   47   98 
Region of Enrollment 
[Units: Participants]
     
United States   60   61   121 
Height 
[Units: Centimeter (cm)]
Mean (Standard Deviation)
 172.10  (8.564)   173.33  (9.206)   172.72  (8.878) 
Weight 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
 95.35  (21.199)   100.88  (19.490)   98.14  (20.460) 
Body Mass Index (BMI) 
[Units: Kilogram per square meter (kg/m^2)]
Mean (Standard Deviation)
 31.99  (5.133)   33.55  (5.913)   32.78  (5.572) 
BMI Category 
[Units: Participants]
     
18.5 - <25   3   3   6 
25 - <30   18   17   35 
>=30   39   41   80 
Smoking History 
[Units: Participants]
     
Never smoked   32   30   62 
Current smoker   8   10   18 
Ex-smoker   20   21   41 
Alcohol History 
[Units: Participants]
     
Never Drunk   26   20   46 
Current Drinker   32   37   69 
Ex-Drinker   2   4   6 
Renal Function [1] 
[Units: Participants]
     
Moderately Impaired   8   5   13 
Mildly Impaired   33   30   63 
Normal   19   26   45 
[1] Renal function categories were defined by estimated glomerular filtration rate (eGFR) calculated based on modification of diet in renal disease (MDRD) formula. Moderately impaired = eGFR 30 to 59 milliliter per minute (mL/min); mildly impaired = eGFR 60 to 89 mL/min; normal renal function=eGFR >=90 mL/min.
Baseline serum uric acid (sUA) 
[Units: Participants]
     
< 8.0 milligram per deciliter (mg/dL)   40   47   87 
>=8.0 mg/dL   20   14   34 
Baseline Medication [1] 
[Units: Participants]
     
ARB or ACEi   26   28   54 
None   34   33   67 
[1] Baseline medication included angiotensin receptor blocker (ARB) and angiotensin-converting enzyme inhibitors (ACEi).


  Outcome Measures
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1.  Primary:   Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6   [ Time Frame: Baseline and Week 6 ]

2.  Secondary:   Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6   [ Time Frame: Baseline and Week 6 ]

3.  Secondary:   Change From Baseline in Serum Urate Levels at Week 6   [ Time Frame: Baseline and Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: clinicaltrialregistry@tpna.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01496469     History of Changes
Other Study ID Numbers: TMX-67_206
U1111-1124-4638 ( Registry Identifier: WHO )
Study First Received: December 18, 2011
Results First Received: July 31, 2015
Last Updated: July 31, 2015
Health Authority: United States: Food and Drug Administration