NCT01328769

Brief Summary

In this study the investigators will recruit hypertensive subjects with higher than average uric acid levels to test the effect of lowering uric acid with febuxostat on several measures as listed below. This will be a randomized, double-blind, placebo-controlled, parallel group study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Mar 2011

Typical duration for phase_4 hypertension

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

March 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

September 17, 2015

Completed
Last Updated

September 17, 2015

Status Verified

July 1, 2015

Enrollment Period

2.5 years

First QC Date

March 29, 2011

Results QC Date

July 7, 2015

Last Update Submit

August 13, 2015

Conditions

Hypertension

Keywords

uric acidfebuxostathypertensionintra-renal renin-angiotensin systemrenal plasma flowangiotensin II

Outcome Measures

Primary Outcomes (1)

  • Change in Renal Plasma Flow in Response to Infused Angiotensin II

    Baseline to 6 weeks

Secondary Outcomes (1)

  • Change in Endothelial Function

    Baseline to 6 weeks

Study Arms (2)

Febuxostat

ACTIVE COMPARATOR

Investigational

Drug: Febuxostat

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

FebuxostatDRUG
Febuxostat
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mild to moderate hypertension. For purposes of this study, the investigators define mild to moderate hypertension as being on no more than 1-2 antihypertensive medications and blood pressure \<140 mm Hg systolic and \<90 mm Hg diastolic based on mean seated blood pressure at the screening visit in our clinic. For these visits, the investigators measure blood pressure using a Dinamap automatic oscillometric cuff while subjects are seated quietly. The subjects are left in a quiet room without speaking for 5 minutes initially. The Dinamap is started and the technician leaves the room and 3 blood pressures are obtained at intervals of 2 minutes. The investigators use the mean of last 2 blood pressures for classification purposes. This is the approach the investigators have used in several multicenter studies including HyperGEN and the NHLBI Family Heart Study.
  • Age 18 to 60.
  • Uric acid =5.8 mg/dl. This was the mean uric acid among hypertensives in our prior study.11 As renal plasma flow response to Ang II infusion decreased linearly with higher uric acid, the investigators felt that using higher than average uric acid will provide greater power.

You may not qualify if:

  • Severe or poorly controlled hypertension (treated blood pressure \>160 mm Hg systolic or \>100 mm Hg diastolic).
  • Diabetes (type 1 or type 2).
  • Estimated GFR \<60 ml/min.
  • Persons unable stop all medications (including antihypertensives) other than stable doses of thyroxine or estrogen for at least 2 weeks.
  • Secondary hypertension.
  • Prior history of clinically diagnosed coronary artery disease or congestive heart failure.
  • Taking uric acid lowering medication within 1 month of screening visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Genetics, University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Paul Hopkins
Organization
University of Utah
paul.hopkins@utah.edu
801-585-8139

Study Officials

  • Paul N Hopkins

    Cardiovascular Genetics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

March 29, 2011

First Posted

April 5, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2013

Study Completion

January 1, 2014

Last Updated

September 17, 2015

Results First Posted

September 17, 2015

Record last verified: 2015-07

Locations

US(1)