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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1124-4638 | Registry Identifier | WHO |
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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).
This study is designed to evaluate the effect of febuxostat during 6 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Febuxostat 80 mg QD | Experimental | Febuxostat 80 mg, tablets, orally, once daily for up to 6 weeks. |
|
| Placebo QD | Placebo Comparator | Febuxostat placebo-matching tablets, orally, once daily for up to 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Febuxostat | Drug | Febuxostat 80 mg, tablets, orally, once daily for up to 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foley | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29102979 | Derived | 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. |
| Label | URL |
|---|---|
| Uloric Package Insert | View source |
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Participants with a historical diagnosis of hypertension along with hyperuricemia were enrolled in 1 of 2 treatment groups as follows: Placebo; Febuxostat 80 milligram (mg).
Participants took part at 29 sites in the United States from 10 January 2012 to 04 August 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks. |
| FG001 | Febuxostat 80 mg | Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Febuxostat placebo-matching tablets, orally, once daily for up to 6 weeks. |
|
| Baseline and Week 6 |
| Change From Baseline in Serum Urate Levels at Week 6 | Baseline and Week 6 |
| Buena Park |
| California |
| United States |
| Carmichael | California | United States |
| Fresno | California | United States |
| Irvine | California | United States |
| Lomita | California | United States |
| Paramount | California | United States |
| Sacramento | California | United States |
| San Diego | California | United States |
| Wildomar | California | United States |
| Milford | Connecticut | United States |
| Fort Lauderdale | Florida | United States |
| Miami | Florida | United States |
| Tallahassee | Florida | United States |
| Tampa | Florida | United States |
| Dunwoody | Georgia | United States |
| Roswell | Georgia | United States |
| Suwanee | Georgia | United States |
| Avon | Indiana | United States |
| Indianapolis | Indiana | United States |
| Lexington | Kentucky | United States |
| Biddeford | Maine | United States |
| City of Saint Peters | Missouri | United States |
| St Louis | Missouri | United States |
| Henderson | Nevada | United States |
| Las Vegas | Nevada | United States |
| Albuquerque | New Mexico | United States |
| Glens Falls | New York | United States |
| Greensboro | North Carolina | United States |
| Salisbury | North Carolina | United States |
| Shelby | North Carolina | United States |
| Fargo | North Dakota | United States |
| Cincinnati | Ohio | United States |
| Columbus | Ohio | United States |
| Lyndhurst | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Portland | Oregon | United States |
| Tipton | Pennsylvania | United States |
| Carrollton | Texas | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Burke | Virginia | United States |
| Manassas | Virginia | United States |
| Port Orchard | Washington | United States |
| Madison | Wisconsin | United States |
| COMPLETED |
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| NOT COMPLETED |
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The Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks. |
| BG001 | Febuxostat 80 mg | Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | centimeter (cm) |
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| Weight | Mean | Standard Deviation | kilogram (kg) |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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| BMI Category | Number | participants |
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| Smoking History | Number | participants |
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| Alcohol History | Number | participants |
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| Renal Function | Renal function categories were defined by estimated glomerular filtration rate (eGFR) calculated based on modification of diet in renal disease (MDRD) formula. Moderately impaired = eGFR 30 to 59 milliliter per minute (mL/min); mildly impaired = eGFR 60 to 89 mL/min; normal renal function=eGFR >=90 mL/min. | Number | participants |
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| Baseline serum uric acid (sUA) | Number | participants |
| ||||||||||||||||
| Baseline Medication | Baseline medication included angiotensin receptor blocker (ARB) and angiotensin-converting enzyme inhibitors (ACEi). | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline and Week 6 |
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| Secondary | 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. | 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. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline and Week 6 |
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| Secondary | Change From Baseline in Serum Urate Levels at Week 6 | 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. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and Week 6 |
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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.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks. | 1 | 60 | 1 | 60 | ||
| EG001 | Febuxostat 80 mg | Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week. | 1 | 61 | 3 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery insufficiency | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (15.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 45 - <65 years |
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| Greater than or equal to (>=) 65 years |
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| Male |
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| Asian |
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| Black or African American |
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| White |
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| More than one race |
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| Not Hispanic or Latino |
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| 25 - <30 |
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| >=30 |
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| Current smoker |
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| Ex-smoker |
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| Current Drinker |
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| Ex-Drinker |
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| Mildly Impaired |
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| Normal |
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| >=8.0 mg/dL |
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| None |
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