Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(unable to enroll participants)
Sponsor:
Information provided by (Responsible Party):
Deborah Minor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01701622
First received: January 27, 2010
Last updated: February 8, 2013
Last verified: December 2012
Results First Received: November 9, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Blood Pressure
Gout
Intervention: Drug: febuxostat

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment - January 2010 - October 2011 Medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No significant events or approaches to report.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Allopurinol, Febuxostat  
STARTED     1  
COMPLETED     1  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
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.


Baseline Measures
    Allopurinol, Febuxostat  
Number of Participants  
[units: participants]
  1  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     1  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  60  
Gender  
[units: participants]
 
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     1  
Blood pressure  
[units: mm Hg]
Mean ± Standard Deviation
 
Diastolic Blood Pressure     79  
Systolic Blood Pressure     131  



  Outcome Measures

1.  Primary:   BP Differences While on Allopurinol and Febuxostat by Clinic and Pressure Readings and 24-hour Ambulatory Blood Pressure Readings.   [ Time Frame: Participants will be followed for an expected average of 4 to 5 weeks. ]

2.  Secondary:   If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)   [ Time Frame: Participants will be followed for an expected average of 4 to 5 weeks. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
Early termination leading to no subjects analyzed


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Debbie Minor
Organization: University of Mississippi Medical Center
phone: 601-984-6888
e-mail: DMinor@umc.edu


No publications provided


Responsible Party: Deborah Minor, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01701622     History of Changes
Other Study ID Numbers: 2009-0186
Study First Received: January 27, 2010
Results First Received: November 9, 2012
Last Updated: February 8, 2013
Health Authority: United States: Institutional Review Board