HypertensionPhase 2NCT01496469

Effect of Febuxostat on Blood Pressure

A Phase 2 study testing Febuxostat in people with Hypertension, run by Takeda at 45 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Febuxostat
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: 45 sitesUnited States
Study dates: Feb 2012to Aug 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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.

Who cannot join

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.

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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.
The participant has a history of alcoholism or illicit drug abuse within 5 years prior to the Screening Visit or is currently consuming >14 alcoholic drinks per week.
The participant has a known hypersensitivity or allergies to febuxostat or any components of the formulations of this compound.
The participant is taking or expected to take a medication as described in the excluded medication section.
The participant has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. This criterion does not apply to those participants with successfully resected basal cell or stage I squamous cell carcinoma of the skin.
The participant's estimated glomerular filtration rate (eGFR) is <30 mL/min/1.73m3, where eGFR is calculated by the Central Laboratory using the Modification of Diet in Renal Disease (MDRD) formula at the Day -21 Screening Visit.
The participant is noncompliant (<80% or >120%) with study medication during Placebo Run-In Period.
The participant has an upper arm circumference less than 24 cm or greater than 42 cm.
The participant's work shift includes any hour between 11 PM (2300) to 7 AM (0700).
The participant has a baseline 24-hour ABPM reading of insufficient quality (as described in Appendix F of the protocol).

Trial locations and contacts

45 sites in 1 country.

City, postcode or hospital

45 sites in 1 country

United States45 sites

Study site
Albuquerque, New Mexico
Study site
Avon, Indiana
Study site
Biddeford, Maine
Study site
Buena Park, California
Study site
Burke, Virginia
Study site
Carmichael, California
Study site
Carrollton, Texas
Study site
Cincinnati, Ohio
Study site
City of Saint Peters, Missouri
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Dunwoody, Georgia
Study site
Fargo, North Dakota
Study site
Foley, Alabama
Study site
Fort Lauderdale, Florida
Study site
Fresno, California
Study site
Glens Falls, New York
Study site
Greensboro, North Carolina
Study site
Henderson, Nevada
Study site
Indianapolis, Indiana
Study site
Irvine, California
Study site
Las Vegas, Nevada
Study site
Lexington, Kentucky
Study site
Lomita, California
Study site
Lyndhurst, Ohio
Study site
Madison, Wisconsin
Study site
Manassas, Virginia
Study site
Miami, Florida
Study site
Milford, Connecticut
Study site
Oklahoma City, Oklahoma
Study site
Paramount, California
Study site
Port Orchard, Washington
Study site
Portland, Oregon
Study site
Roswell, Georgia
Study site
Sacramento, California
Study site
Salisbury, North Carolina
Study site
San Antonio, Texas
Study site
San Diego, California
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Shelby, North Carolina
Study site
St Louis, Missouri
Study site
Suwanee, Georgia
Study site
Tallahassee, Florida
Study site
Tampa, Florida
Study site
Tipton, Pennsylvania
Study site
Wildomar, California

Other trials in United States

About this study

Official title: A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Effect of Febuxostat 80 mg Once Daily Compared to Placebo on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension

Read the detailed description

This study is designed to evaluate the effect of febuxostat during 6 weeks of treatment.

Conditions: Hypertension
Being tested: Febuxostat, Placebo
Keywords: Drug Therapy
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FebuxostatDrug
Also called TMX-67, Uloric
Febuxostat 80 mg, tablets, orally, once daily for up to 6 weeks
PlaceboDrug
Febuxostat placebo-matching tablets, orally, once daily for up to 6 weeks.

Study groups in NCT01496469
Study group	Role	What they receive
Febuxostat 80 mg QD	Experimental	Febuxostat 80 mg, tablets, orally, once daily for up to 6 weeks. Receives: Drug: Febuxostat
Placebo QD	Placebo comparator	Febuxostat placebo-matching tablets, orally, once daily for up to 6 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
The change in 24-hour mean DBP 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.
Measured: Baseline and Week 6
Change From Baseline in Serum Urate Levels at Week 6
Measured: Baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Aug 2014

First posted21 Dec 2011 (estimated)
Study startFeb 2012
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01496469
Sponsor's protocol ID: TMX-67_206
Other IDs: U1111-1124-4638
Status last verified: Jul 2015
First submitted: 18 Dec 2011
Last updated: 31 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 29102979

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Double-Blind, Placebo-Controlled Study to Assess the Effect of Febuxostat 80 mg Once Daily Compared to Placebo on Ambulatory Blood Pressure in Subjects With Hyperuricemia and Hypertension
ClinicalTrials.gov ID: NCT01496469
Acronym / sponsor ID: TMX-67_206
Conditions: Hypertension
Keywords: Drug Therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 21 Dec 2011 (estimated)
Results: Posted 31 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study is designed to evaluate the effect of febuxostat during 6 weeks of treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Febuxostat 80 mg QD	Experimental	Drug: FebuxostatFebuxostat 80 mg, tablets, orally, once daily for up to 6 weeks.
Placebo QD	Placebo comparator	Drug: PlaceboFebuxostat placebo-matching tablets, orally, once daily for up to 6 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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:

Key exclusion criteria (24 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FebuxostatAlso: TMX-67, UloricFebuxostat 80 mg, tablets, orally, once daily for up to 6 weeks	Drug	Febuxostat 80 mg QD
PlaceboFebuxostat placebo-matching tablets, orally, once daily for up to 6 weeks.	Drug	Placebo QD

Primary outcome

Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6
Time frame: Baseline and 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.

2 secondary outcomes

Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6
Time frame: Baseline and Week 6
Change From Baseline in Serum Urate Levels at Week 6
Time frame: Baseline and Week 6

Results and safety

Results posted to the registry on 31 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	60	50
Febuxostat 80 mg	61	53

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

Time frame: Baseline and Week 6. Least squares mean (Standard Error). Unit: millimeters of mercury (mmHg)

Measure	Placebo n = 53	Febuxostat 80 mg n = 56
Baseline	142.3 (1.21)	139.5 (1.18)
Change at Week 6	-3.4 (1.31)	-3.7 (1.27)

Placebo vs Febuxostat 80 mg: Least Squares Mean Difference: -0.3 (95% CI -3.9 to 3.4), p = 0.882, ANCOVA

Population analysed: FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent AEs are defined as any AEs, regardless of relationship to study drug, which occurs on or after the first double-blind dose date and up to 30 days after the last dose date of the double-blind study drug.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 60 (1.7%)	1 of 60 (1.7%)	Not reported
Febuxostat 80 mg	1 of 61 (1.6%)	3 of 61 (4.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29102979Gunawardhana 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.
Uloric Package InsertLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director, Clinical Science study director

Takeda

45 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Febuxostat in people with Hypertension, run by Takeda at 45 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6 (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01496469, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2015.