Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure
This study has been completed.
Sponsor:
University of California, San Diego
Information provided by (Responsible Party):
Daniel O'Connor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01472692
First received: November 13, 2011
Last updated: March 31, 2014
Last verified: March 2014
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Purpose
High normal blood pressure, also called prehypertension, is a significant problem. High uric acid in the blood, the same thing that causes gout, may cause higher blood pressures. The investigators plan to monitor the effects of the drug febuxostat(trade name Uloric) on blood pressure and stiffness of the main blood vessels and see if lowering uric acid has any effect.
| Condition | Intervention | Phase |
|---|---|---|
|
Prehypertension Gout Pulse Wave Velocity Hypertension 24 Hour Blood Pressure |
Drug: Febuxostat |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive |
Resource links provided by NLM:
Further study details as provided by University of California, San Diego:
Primary Outcome Measures:
- Changes in 24 hour blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Changes in Pulse wave velocity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 47 |
| Study Start Date: | October 2011 |
| Study Completion Date: | March 2014 |
| Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Febuxostat |
Drug: Febuxostat
80mg PO daily for 8 weeks
Other Name: Uloric
|
| Placebo Comparator: Placebo |
Drug: Febuxostat
80mg PO daily for 8 weeks
Other Name: Uloric
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Prehypertensive male and female subjects with SBP =120-140 mmHg or DBP =80-90 mmHg (as determined by seated office BP).
- Plasma uric acid level ≥5 mg/dl
- Ages 18-50
- non-smokers
- Subjects will need to remain in the San Diego area for the duration of the study and be accessible by telephone or email.
Exclusion Criteria:
- no current smoking in the prior 6 months.
- Any history of any serious medical conditions requiring close monitoring from physicians- such as liver impairment, chronic kidney disease, or diabetes mellitus. Participants not currently under the care of a physician for these conditions will be eligible for the study.
- Any history of gout, hypertension, hypercholesterolemia, morbid obesity.
- Any history of use xanthine oxidase inhibitors, antihypertensives, antiglycemic, and cholesterol lowering medications
- any history of illicit drug use within the last 6 months
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01472692
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472692
Locations
| United States, California | |
| Univerisity Of California San Diego | |
| San Diego, California, United States, 92037 | |
Sponsors and Collaborators
University of California, San Diego
Investigators
| Principal Investigator: | Daniel O'Connor, UCSD | UCSD |
| Study Director: | Jason T. Davis, M.D. | University of California, San Diego |
More Information
| Responsible Party: | Daniel O'Connor, M.D. Professor of Medicine, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT01472692 History of Changes |
| Other Study ID Numbers: | 110806 |
| Study First Received: | November 13, 2011 |
| Last Updated: | March 31, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
|
Prehypertension Gout Puls Wave Velocity Hypertension 24 hour blood pressure |
Additional relevant MeSH terms:
|
Hypertension Prehypertension Vascular Diseases Cardiovascular Diseases |
Febuxostat Gout Suppressants Antirheumatic Agents |
ClinicalTrials.gov processed this record on September 30, 2016