Effect of Febuxostat on Blood Pressure

NCT01496469 | Completed Phase 2 Results DMC

• 2 other identifiers: TMX-67_206U1111-1124-4638
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 45

Brief Summary

The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared to placebo on lowering ambulatory 24-hour mean blood pressure of participants with hypertension and hyperuricemia (not associated with gout).

Conditions

Hypertension

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6

  The change in 24-hour mean SBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.

  Baseline and Week 6

Secondary Outcomes (2)

• Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6

  Baseline and Week 6

• Change From Baseline in Serum Urate Levels at Week 6

  Baseline and Week 6

Study Arms (2)

Febuxostat 80 mg QD

EXPERIMENTAL

Febuxostat 80 mg, tablets, orally, once daily for up to 6 weeks.

Drug: Febuxostat

Placebo QD

PLACEBO COMPARATOR

Febuxostat placebo-matching tablets, orally, once daily for up to 6 weeks.

Drug: Placebo

Interventions

Febuxostat DRUG

Febuxostat 80 mg, tablets, orally, once daily for up to 6 weeks

Also known as: TMX-67, Uloric

Febuxostat 80 mg QD

Placebo DRUG

Febuxostat placebo-matching tablets, orally, once daily for up to 6 weeks.

Placebo QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant has documented hypertension, defined as average clinic systolic blood pressure (SBP) of ≥145 mm Hg and ≤165 mm Hg or average clinic diastolic blood pressure (DBP) of ≥90 mm Hg and ≤105 mm Hg at the Day -21 Screening Visit; the average BP measurement at two of the three Placebo Run-in Visits (Day -14, Day -7 and Day -1) must also meet the above criteria for hypertension.
• The participant has a serum uric acid (sUA) level ≥7.0 mg/dL not associated with gout, at the Day -21 Screening Visit.
• The participant has a 24-hour mean ambulatory SBP of ≥130 mm Hg and \< 165 mm Hg at the Baseline (Day 1) Visit.
• At the initial Screening Visit (Day -21), the maximum number of antihypertensive medications the participant is taking is ≤ 2 (fixed-dose combination medications are considered 2 medications, including diuretics), and the participant has been on a stable dose of this medication for at least1 month prior to start of the initial Screening Visit (Day -21).
• The participant is male and at least 18 years of age, or a female who is:
• Surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation), OR
• Postmenopausal (defined as at least 1 year since last regular menses with an follicle-stimulating hormone (FSH) \>40 IU/L, or at least 5 years since last regular menses), OR
• On hormone replacement therapy and ≥ 55 years of age.
• The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

You may not qualify if:

• The participant has received any investigational compound within 30 days, or within 5 half-lives of the compound (whichever is longer) prior to the Screening Visit.
• The participant has received febuxostat or any urate-lowering therapy (ULT) in a previous clinical study or as a therapeutic agent.
• The participant has gout, history of gout, or gout flares.
• The participant has secondary hyperuricemia (HPU) (e.g., due to myeloproliferative disorder, or organ transplant).
• The participant has known secondary hypertension of any etiology (e.g., renovascular disease, primary hyperaldosteronism, Cushing syndrome).
• The participant has a history, within the 6 months prior to screening, of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, or percutaneous coronary intervention.
• The participant has an irregular cardiac rhythm (e.g., atrial fibrillation, multifocal premature atrial contractions) which leads to difficulty with interpretation of ambulatory blood pressure monitoring (ABPM).
• The participant has a history of congestive heart failure, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
• The participant has type 1 or poorly controlled type 2 diabetes mellitus (glycosylated hemoglobin \[HbA1c\] \>8.0%) at Screening.
• The participant has a history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
• The participant has an average clinic SBP \>165 mm Hg or DBP \>105 mm Hg at 1 or more visits during the Placebo Run-in Period.
• The participant's average clinic SBP or DBP measurement that increases or decreases by \>10 mm Hg between Placebo Run-in visits (Day -14 to Day -7, or Day -7 to Day -1, or Day -14 to Day -1).
• The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
• The participant has an alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values greater than 2.0 times the upper limit of normal (ULN).
• The participant has a significant medical condition and/or conditions that would interfere with the treatment, safety or compliance with the protocol.

Sponsors & Collaborators

• Takeda: lead

Study Sites (45)

Unknown Facility

Foley, Alabama, United States

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Buena Park, California, United States

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Carmichael, California, United States

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Fresno, California, United States

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Irvine, California, United States

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Lomita, California, United States

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Paramount, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Wildomar, California, United States

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Milford, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Miami, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Dunwoody, Georgia, United States

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Roswell, Georgia, United States

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Suwanee, Georgia, United States

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Avon, Indiana, United States

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Indianapolis, Indiana, United States

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Lexington, Kentucky, United States

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Biddeford, Maine, United States

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City of Saint Peters, Missouri, United States

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St Louis, Missouri, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Glens Falls, New York, United States

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Greensboro, North Carolina, United States

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Salisbury, North Carolina, United States

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Shelby, North Carolina, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Lyndhurst, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Tipton, Pennsylvania, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Burke, Virginia, United States

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Manassas, Virginia, United States

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Port Orchard, Washington, United States

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Madison, Wisconsin, United States

Location

Related Publications (1)

• Gunawardhana L, McLean L, Punzi HA, Hunt B, Palmer RN, Whelton A, Feig DI. Effect of Febuxostat on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension: A Phase 2 Randomized Placebo-Controlled Study. J Am Heart Assoc. 2017 Nov 4;6(11):e006683. doi: 10.1161/JAHA.117.006683.

  PMID: 29102979 DERIVED

Related Links

• Uloric Package Insert

MeSH Terms

Conditions

Hypertension

Interventions

Febuxostat

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

clinicaltrialregistry@tpna.com

+1-877-825-3327

Study Officials

• Medical Director, Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2011
• First Posted: December 21, 2011
• Study Start: February 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 31, 2015
• Results First Posted: August 31, 2015

Record last verified: 2015-07

Locations

US (45)