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OpenTrials
Completed

NCT Number: NCT01472692

Study of Febuxostat Effect on Blood Pressure in Patients With High Normal Blood Pressure

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.

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Key information

Conditions

Prehypertension 24 Hour Blood Pressure Arthritis Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Hypertension Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pulse Wave Velocity Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Univerisity Of California San Diego

San Diego, California, 92037, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Febuxostat

Drug

80mg PO daily for 8 weeks

Other names: Uloric

Primary outcomes

  1. Changes in 24 Hour Blood Pressure

    Time frame: 8 weeks

  2. Changes in Pulse Wave Velocity

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Treatment of Uric Acid With the Xanthine Oxidase Inhibitor Febuxostat: Effects on Blood Pressure, Metabolic Markers, and Aortic Stiffness in Prehypertensive

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 16, 2011
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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