NCT01472692

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

December 16, 2019

Completed
Last Updated

December 16, 2019

Status Verified

November 1, 2019

Enrollment Period

2.4 years

First QC Date

November 13, 2011

Results QC Date

November 26, 2019

Last Update Submit

November 26, 2019

Conditions

PrehypertensionGoutPulse Wave VelocityHypertension24 Hour Blood Pressure

Keywords

PrehypertensionGoutPuls Wave VelocityHypertension24 hour blood pressure

Outcome Measures

Primary Outcomes (2)

  • Changes in 24 Hour Blood Pressure

    8 weeks

  • Changes in Pulse Wave Velocity

    8 weeks

Study Arms (2)

Febuxostat

ACTIVE COMPARATOR
Drug: Febuxostat

Placebo

PLACEBO COMPARATOR
Drug: Febuxostat

Interventions

FebuxostatDRUG

80mg PO daily for 8 weeks

Also known as: Uloric
FebuxostatPlacebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerisity Of California San Diego

San Diego, California, 92037, United States

Location

Related Publications (1)

  • Gois PHF, Souza ERM. Pharmacotherapy for hyperuricaemia in hypertensive patients. Cochrane Database Syst Rev. 2020 Sep 2;9(9):CD008652. doi: 10.1002/14651858.CD008652.pub4.

    PMID: 32877573DERIVED

MeSH Terms

Conditions

PrehypertensionGoutHypertension

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

The Principal Investigator for this study has passed away and the results data is not available.

Results Point of Contact

Title
Department of Medicine
Organization
UCSD
(858) 552-8585

Study Officials

  • Daniel O'Connor, UCSD

    UCSD

    PRINCIPAL INVESTIGATOR

  • Jason T. Davis, M.D.

    University of California, San Diego

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2011

First Posted

November 16, 2011

Study Start

October 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 16, 2019

Results First Posted

December 16, 2019

Record last verified: 2019-11

Locations

US(1)