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Febuxostat for Cerebral and caRdiorenovascular Events prEvEntion stuDy (FREED)

Primary Purpose

Hyperuricemia

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Febuxostat
Sponsored by
Freed Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperuricemia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (1) Patients 65 years of age or older at enrollment who are able to visit
  • (2) Patients with hyperuricemia, who have a serum uric acid level >7.0 mg/dL and <= 9.0 mg/dL (7.0 mg/dL < serum uric acid level <= 9.0 mg/dL) within 2 months prior to enrollment
  • (3) Patients at risk for any of the cerebral or cardiorenovascular diseases in i) through iv) below (i) Previous or current history of hypertension (ii) Previous or current history of type 2 diabetes mellitus (iii) Renal disorders (30 mL/min/1.73 m2 <= eGFR < 60 mL/min/1.73 m2 within 3 months prior to enrollment) (iv) Previous history of cerebral or cardiorenovascular disease for more than 3 months prior to enrollment (stroke [cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage], coronary artery disease, vascular disease, or cardiac failure)
  • (4) Patients who personally give written informed consent to participate in this study

Exclusion Criteria:

  • (1) Patients with gouty tophus, or patients with subjective symptoms of gouty arthritis within 1 year prior to enrollment
  • (2) Patients with a previous history of hypersensitivity to febuxostat or allopurinol
  • (3) Patients with malignant tumors
  • (4) Patients with serious kidney disease, Acute kidney disease, nephrotic syndrome, dialysis patients, kidney transplant patients, eGFR < 30 mL/min/1.73 m2 , etc.
  • (5) Patients with a previous history of acute coronary syndrome or stroke within 3 months prior to enrollment (cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage)
  • (6) Patients with a >= 50% increase in serum creatinine within 3 months prior to enrollment
  • (7) Patients with severe hypertension characterized by systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg within 3 months prior to enrollment
  • (8) Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 or more times the upper limit of normal within 3 months prior to enrollment
  • (9) Patients on any of the following medications at enrollment Mercaptopurine hydrate, azathioprine, vidarabine, or didanosine
  • (10) Patients who receive any of the following medications for the treatment of hyperuricemia within 1 month prior to enrollment Allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, or febuxostat
  • (11) Patients who start, modify the dose of, or discontinue any of the following medications within 1 month prior to enrollment Losartan, irbesartan, fenofibrate, thiazide diuretics, or loop diuretics
  • (12) Patients on hormone replacement therapy with estrogen (estrogenic hormone products)
  • (13) Patients who have participated in other clinical research (including trials) within 6 months prior to enrollment (non-interventional observational research not excluded)
  • (14) Patients otherwise judged by the principal or sub-investigator to be unsuitable for the study

Sites / Locations

  • Hiramitsu Heart Clinic
  • Ogawa-naika Clinic
  • Shakaiiryohoｊin Koｊunkai Daido Hospital
  • Honjo Daiichi Hospital
  • Iriyouhoujin Siyadan Yanagisawakai Yanagisawaiin
  • Matsuno Medical Clinic
  • Ishite Matsumoto Naika Junkanki Clinic
  • Ehime Medical CO-OP Izumigawa Clinic
  • Hanaoka IC Clinic
  • Otonari Clinic
  • Medical Cooperation Toseikai Goto Clinic
  • ONGA NAKAMA Medical Association ONGA Hospital
  • Southern Tohoku Research Institute For Neuroscience Southern Tohoku Medical Clinic
  • Noda Clinic
  • Sunomata Clinic
  • Tsurugaya Hospital
  • Nakano Clinic
  • Iryouhoujinn Makikai Makibyouinn
  • Shigenobu Clinic
  • Keiyukai Yoshida Hospital
  • Matsui Naika Clinic
  • Omiya Clinic
  • Miyanomori Memorial Hospital
  • Okamoto Naika Clinic
  • River Side Clinic
  • Katsuya Iin
  • Kousei Hospital
  • Nakatani Hospital
  • Harima Clinic
  • Kusunose Surgery Clinic
  • Yamaki Medical Clinic
  • Shika Clinic
  • Yanagi Medical Clinic
  • Kakuda Iin
  • Dr Hayakawa's Family Clinic
  • Wakasa Medical Clinic
  • Okyozuka Clinic
  • Matsuoka Clinic
  • Ori Clinic
  • Iroden Clinic
  • Nagasu Clinic
  • Shohei Clinic
  • Kamegaya Clinic
  • Kobayashi Hospital
  • Hakuai Iin
  • Yamamoto Clinic
  • International Goodwill Hospital
  • Kikuchi Clinic
  • Shimokurata Heart Clinic
  • Tani Clinic Internal Medicine, Allergology & Rheumatology
  • Tsurumi Chuo Clinic
  • Yamagami Naika
  • Yokohama City University Medical Center
  • Yokohama Sotetsu bldg Clinic of Internal Medicine
  • Toihata Naika
  • Omori Iin
  • Kan Kaimeido Clinic
  • Matsuo Clinic
  • Miyagi clinic cardiovascular medicine
  • Iwasaki Hospital
  • Eto Clinic
  • Kawano Clinic
  • Miyata Naika Iin
  • Nara Medical University Hospital
  • Ote Clinic of Internal
  • Uchiyama Clinic
  • Hospital, University of the Ryukyus
  • Nishimura Clinic
  • Ikeda Clinic
  • Kanazawa Clinic
  • Hayashi Medical Clinic
  • Matsuo Clinic
  • Enomoto Clinic
  • Saitama Medical Center
  • Iryohojin Hogi sinryojyo
  • Okuaki Clinic
  • Tokutake Iin
  • Medical Corporation Shibuya Clinic
  • Ota Clinic
  • Minami National Health Insurance Hospital Of Minami Town
  • Sekishinkan Hospital
  • Tanaka Clinic
  • Harada Clinic
  • Johoku Clinic
  • Moritani Clinic
  • Nishimura Memorial Hospital
  • Hosoda-Clinic
  • Okuda clinic
  • Tenjinmae Clinic
  • Daiba Shinryojo
  • Kurumatani Clinic
  • Oono Iin
  • Sugawara Clinic
  • Baba Iin
  • Miyahara Clinic
  • Taguchi Clinic
  • Tokyo Women's Medical University Hospital
  • Kobayashi Clinic
  • Tominaga Clinic
  • Kirino Clinic
  • Yamada Clinic
  • Ayame Medical Clinic
  • Matuda Clinic
  • Kuroda Iin
  • Saku Hospital
  • Tohaya Iin
  • Iryohojin Shadan Seijinkai Kawade Iin
  • Kawai Naika Clinic
  • Miwa Clinic: Gastroenterology Hepatology
  • Sagou Clinic
  • Sasaki Clinic
  • Takai Clinic
  • Takeda Clinic
  • Totani Medical Clinic
  • Shimamoto Hospital
  • Honjo Internal Medicine Hospital
  • Jinnouchi Clinic Diabetes Care Center
  • Kumamoto University Hospital
  • Maki Cardiovascular Clinic
  • Otsuka Hospital
  • Suizenji Touya Hospital
  • TERAO Hospital
  • Isoda Internal Medical Clinic
  • Koseikai Clinic
  • Takenaka Clinic
  • Yokota Naika
  • Maeda Medical Clinic
  • Akioka Clinic
  • Kinugawa Cardiology Clinic
  • Kondo Clinic
  • Kubota Clinic
  • Matsushita Medical Clinic
  • Nanko Clinic
  • Seo Heart Clinic
  • Watanabe Iin
  • Harada Medical Clinic
  • Shizuoka Municipal Hospital
  • Waki Riichiro Clinic
  • Itsumo Smile Clinic
  • Shimasaki Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Febuxostat treatment group

Non-febuxostat treatment group

Arm Description

Once daily after breakfast (generally within 30 minutes after eating)

No febuxostat treatment

Outcomes

Primary Outcome Measures

Development of cerebral or cardiorenovascular events and all deaths
Definition of "cerebral and cardiorenovascular events": Death due to cerebral or cardiorenovascular disease New or recurrent cerebrovascular disease (stroke [cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, stroke of unknown type], transient ischemic attack New or recurrent non-fatal coronary artery disease (myocardial infarction and unstable angina pectoris) Cardiac failure requiring hospitalization Arteriosclerotic disease requiring hospitalization (aortic aneurysm, aortic dissection, and arteriosclerosis obliterans) Renal impairment (development of microalbuminuria, progression to overt proteinuria, or overt proteinuria [≥ 300 mg/gCr], confirmed by two consecutive laboratory tests performed after the initiation of study treatments; doubling of serum creatinine level; and progression to ESRD) New atrial fibrillation (including paroxysmal atrial fibrillation) Deaths that are not caused by cerebral or cardiorenovascular disease

Secondary Outcome Measures

Occurrence of cerebral or cardiorenovascular event by event
Occurrence of cerebral or cardiorenovascular event by serum uric acid level
Occurrence of cerebral or cardiorenovascular event by prior history of cerebral or cardiorenovascular disease
Serum uric acid level
Change in serum uric acid level
Amount of change and percent change in serum uric acid level
Amount of change and percent change in serum uric acid level
Amount of change and percent change in serum uric acid level
Amount of change and percent change in serum uric acid level
Amount of change and percent change in serum uric acid level
Amount of change and percent change in serum uric acid level
Amount of change and percent change in serum uric acid level
Amount of change and percent change in serum uric acid level
Percent Achieving serum uric acid level of 6.0mg/dL
Estimated glomerular filtration rate (eGFR)
Amount of change and percent change in eGFR
Amount of change and percent change in eGFR
Amount of change and percent change in eGFR
Amount of change and percent change in eGFR
Amount of change and percent change in eGFR
Amount of change and percent change in eGFR
Amount of change and percent change in eGFR
Amount of change and percent change in eGFR
Amount of change and percent change in eGFR
Urine microalbumin-creatinine ratio
Amount of change and percent change in urine microalbumin-creatinine ratio
Amount of change and percent change in urine microalbumin-creatinine ratio
Amount of change and percent change in urine microalbumin-creatinine ratio
Amount of change and percent change in urine microalbumin-creatinine ratio
Quantification of urinary protein
Amount of change and percent change in quantified urinary protein
Amount of change and percent change in quantified urinary protein
Amount of change and percent change in quantified urinary protein
Amount of change and percent change in quantitative urinary protein
Blood pressure (systolic/diastolic)
Amount of change and percent change in blood pressure (systolic/diastolic)
Amount of change and percent change in blood pressure (systolic/diastolic)
Amount of change and percent change in blood pressure (systolic/diastolic)
Amount of change and percent change in blood pressure (systolic/diastolic)
Amount of change and percent change in blood pressure (systolic/diastolic)
Amount of change and percent change in blood pressure (systolic/diastolic)
Occurrence of adverse events
Occurrence of cerebral or cardiorenovascular events in the febuxostat group during the study period by febuxostat dose
Occurrence of cerebral or cardiorenovascular events in the non-febuxostat group during the study period by use of allopurinol

Full Information

First Posted
October 30, 2013
Last Updated
August 25, 2016
Sponsor
Freed Study Group
Collaborators
Teijin Pharma Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01984749
Brief Title
Febuxostat for Cerebral and caRdiorenovascular Events prEvEntion stuDy
Acronym
FREED
Official Title
A Multicenter, Randomized, Comparative Trial on the Effect of Febuxostat in Preventing Cerebral and Cardiorenovascular Events in Patients With Hyperuricemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Freed Study Group
Collaborators
Teijin Pharma Limited

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to demonstrate the effect of febuxostat in preventing cerebral and cardiorenovascular events in elderly patients with hyperuricemia who are at risk for cerebral and cardiorenovascular disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Febuxostat treatment group
Arm Type
Experimental
Arm Description
Once daily after breakfast (generally within 30 minutes after eating)
Arm Title
Non-febuxostat treatment group
Arm Type
No Intervention
Arm Description
No febuxostat treatment
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Intervention Description
Febuxostat will be taken once daily after breakfast (generally within 30 minutes after eating) but can be taken around the time of breakfast even if no food has been eaten. When the dose is to be increased, the principal or sub-investigator will carry out any required examinations and tests as needed. The starting dose of the investigational product (febuxostat) will be 10 mg/day. The dose will be increased to 20 mg/day at Week 4. The aim is to increase the dose to 40 mg/day at Week 8.
Primary Outcome Measure Information:
Title
Development of cerebral or cardiorenovascular events and all deaths
Description
Definition of "cerebral and cardiorenovascular events": Death due to cerebral or cardiorenovascular disease New or recurrent cerebrovascular disease (stroke [cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, stroke of unknown type], transient ischemic attack New or recurrent non-fatal coronary artery disease (myocardial infarction and unstable angina pectoris) Cardiac failure requiring hospitalization Arteriosclerotic disease requiring hospitalization (aortic aneurysm, aortic dissection, and arteriosclerosis obliterans) Renal impairment (development of microalbuminuria, progression to overt proteinuria, or overt proteinuria [≥ 300 mg/gCr], confirmed by two consecutive laboratory tests performed after the initiation of study treatments; doubling of serum creatinine level; and progression to ESRD) New atrial fibrillation (including paroxysmal atrial fibrillation) Deaths that are not caused by cerebral or cardiorenovascular disease
Time Frame
Enrollment through Month 36
Secondary Outcome Measure Information:
Title
Occurrence of cerebral or cardiorenovascular event by event
Time Frame
Enrollment through Month 36
Title
Occurrence of cerebral or cardiorenovascular event by serum uric acid level
Time Frame
Enrollment through Month 36
Title
Occurrence of cerebral or cardiorenovascular event by prior history of cerebral or cardiorenovascular disease
Time Frame
Enrollment through Month 36
Title
Serum uric acid level
Time Frame
At screening, at enrollment, at 4, 8, and 12 weeks and 6, 12, 18, 24, 30, and 36 months (or at withdrawal from the study)
Title
Change in serum uric acid level
Time Frame
Enrollment through Week 4
Title
Amount of change and percent change in serum uric acid level
Time Frame
Enrollment through Week 8
Title
Amount of change and percent change in serum uric acid level
Time Frame
Enrollment through Week 12
Title
Amount of change and percent change in serum uric acid level
Time Frame
Enrollment through Month 6
Title
Amount of change and percent change in serum uric acid level
Time Frame
Enrollment through Month 12
Title
Amount of change and percent change in serum uric acid level
Time Frame
Enrollment through Month 18
Title
Amount of change and percent change in serum uric acid level
Time Frame
Enrollment through Month 24
Title
Amount of change and percent change in serum uric acid level
Time Frame
Enrollment through Month 30
Title
Amount of change and percent change in serum uric acid level
Time Frame
Enrollment through Month 36 (or withdrawal from the study)
Title
Percent Achieving serum uric acid level of 6.0mg/dL
Time Frame
Enrollment to completion of study or withdrawal
Title
Estimated glomerular filtration rate (eGFR)
Time Frame
Enrollment, 4, 8, and 12 weeks and 6, 12, 18, 24, 30, and 36 months (or withdrawal from the study)
Title
Amount of change and percent change in eGFR
Time Frame
Enrollment through Week 4
Title
Amount of change and percent change in eGFR
Time Frame
Enrollment through Week 8
Title
Amount of change and percent change in eGFR
Time Frame
Enrollment through Week 12
Title
Amount of change and percent change in eGFR
Time Frame
Enrollment through Month 6
Title
Amount of change and percent change in eGFR
Time Frame
Enrollment through Month 12
Title
Amount of change and percent change in eGFR
Time Frame
Enrollment through Month 18
Title
Amount of change and percent change in eGFR
Time Frame
Enrollment through Month 24
Title
Amount of change and percent change in eGFR
Time Frame
Enrollment through Month 30
Title
Amount of change and percent change in eGFR
Time Frame
Enrollment through Month 36 (or withdrawal from the study)
Title
Urine microalbumin-creatinine ratio
Time Frame
Enrollment, 6, 12, 24, and 36 months (or withdrawal from the study)
Title
Amount of change and percent change in urine microalbumin-creatinine ratio
Time Frame
Enrollment through Month 6
Title
Amount of change and percent change in urine microalbumin-creatinine ratio
Time Frame
Enrollment through Month 12
Title
Amount of change and percent change in urine microalbumin-creatinine ratio
Time Frame
Enrollment through Month 24
Title
Amount of change and percent change in urine microalbumin-creatinine ratio
Time Frame
Enrollment through Month 36 (or withdrawal from the study)
Title
Quantification of urinary protein
Time Frame
Enrollment, 6, 12, 24, and 36 months (or withdrawal from the study)
Title
Amount of change and percent change in quantified urinary protein
Time Frame
Enrollment through Month 6
Title
Amount of change and percent change in quantified urinary protein
Time Frame
Enrollment through Month 12
Title
Amount of change and percent change in quantified urinary protein
Time Frame
Enrollment through Month 24
Title
Amount of change and percent change in quantitative urinary protein
Time Frame
Enrollment through Month 36 (or withdrawal from the study)
Title
Blood pressure (systolic/diastolic)
Time Frame
Enrollment, 6, 12, 18, 24, 30, and 36 months (or withdrawal from the study)
Title
Amount of change and percent change in blood pressure (systolic/diastolic)
Time Frame
Enrollment through Month 6
Title
Amount of change and percent change in blood pressure (systolic/diastolic)
Time Frame
Enrollment through Month 12
Title
Amount of change and percent change in blood pressure (systolic/diastolic)
Time Frame
Enrollment through Month 18
Title
Amount of change and percent change in blood pressure (systolic/diastolic)
Time Frame
Enrollment through Month 24
Title
Amount of change and percent change in blood pressure (systolic/diastolic)
Time Frame
Enrollment through Month 30
Title
Amount of change and percent change in blood pressure (systolic/diastolic)
Time Frame
Enrollment through Month 36 (or withdrawal from the study)
Title
Occurrence of adverse events
Time Frame
Enrollment through Month 36
Title
Occurrence of cerebral or cardiorenovascular events in the febuxostat group during the study period by febuxostat dose
Time Frame
Enrollment through Month 36
Title
Occurrence of cerebral or cardiorenovascular events in the non-febuxostat group during the study period by use of allopurinol
Time Frame
Enrollment through Month 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) Patients 65 years of age or older at enrollment who are able to visit (2) Patients with hyperuricemia, who have a serum uric acid level >7.0 mg/dL and <= 9.0 mg/dL (7.0 mg/dL < serum uric acid level <= 9.0 mg/dL) within 2 months prior to enrollment (3) Patients at risk for any of the cerebral or cardiorenovascular diseases in i) through iv) below (i) Previous or current history of hypertension (ii) Previous or current history of type 2 diabetes mellitus (iii) Renal disorders (30 mL/min/1.73 m2 <= eGFR < 60 mL/min/1.73 m2 within 3 months prior to enrollment) (iv) Previous history of cerebral or cardiorenovascular disease for more than 3 months prior to enrollment (stroke [cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage], coronary artery disease, vascular disease, or cardiac failure) (4) Patients who personally give written informed consent to participate in this study Exclusion Criteria: (1) Patients with gouty tophus, or patients with subjective symptoms of gouty arthritis within 1 year prior to enrollment (2) Patients with a previous history of hypersensitivity to febuxostat or allopurinol (3) Patients with malignant tumors (4) Patients with serious kidney disease, Acute kidney disease, nephrotic syndrome, dialysis patients, kidney transplant patients, eGFR < 30 mL/min/1.73 m2 , etc. (5) Patients with a previous history of acute coronary syndrome or stroke within 3 months prior to enrollment (cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage) (6) Patients with a >= 50% increase in serum creatinine within 3 months prior to enrollment (7) Patients with severe hypertension characterized by systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg within 3 months prior to enrollment (8) Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 or more times the upper limit of normal within 3 months prior to enrollment (9) Patients on any of the following medications at enrollment Mercaptopurine hydrate, azathioprine, vidarabine, or didanosine (10) Patients who receive any of the following medications for the treatment of hyperuricemia within 1 month prior to enrollment Allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, or febuxostat (11) Patients who start, modify the dose of, or discontinue any of the following medications within 1 month prior to enrollment Losartan, irbesartan, fenofibrate, thiazide diuretics, or loop diuretics (12) Patients on hormone replacement therapy with estrogen (estrogenic hormone products) (13) Patients who have participated in other clinical research (including trials) within 6 months prior to enrollment (non-interventional observational research not excluded) (14) Patients otherwise judged by the principal or sub-investigator to be unsuitable for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisao Ogawa
Organizational Affiliation
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Official's Role
Study Chair
Facility Information:
Facility Name
Hiramitsu Heart Clinic
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Ogawa-naika Clinic
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Shakaiiryohoｊin Koｊunkai Daido Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Honjo Daiichi Hospital
City
Yurihonjo
State/Province
Akita
Country
Japan
Facility Name
Iriyouhoujin Siyadan Yanagisawakai Yanagisawaiin
City
Matsudo
State/Province
Chiba
Country
Japan
Facility Name
Matsuno Medical Clinic
City
Iyo-gun
State/Province
Ehime
Country
Japan
Facility Name
Ishite Matsumoto Naika Junkanki Clinic
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Ehime Medical CO-OP Izumigawa Clinic
City
Niihama
State/Province
Ehime
Country
Japan
Facility Name
Hanaoka IC Clinic
City
Buzen
State/Province
Fukuoka
Country
Japan
Facility Name
Otonari Clinic
City
Chikushino
State/Province
Fukuoka
Country
Japan
Facility Name
Medical Cooperation Toseikai Goto Clinic
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
ONGA NAKAMA Medical Association ONGA Hospital
City
Onga-gun
State/Province
Fukuoka
Country
Japan
Facility Name
Southern Tohoku Research Institute For Neuroscience Southern Tohoku Medical Clinic
City
Koriyama
State/Province
Fukushima
Country
Japan
Facility Name
Noda Clinic
City
Ibi
State/Province
Gifu
Country
Japan
Facility Name
Sunomata Clinic
City
Ogaki
State/Province
Gifu
Country
Japan
Facility Name
Tsurugaya Hospital
City
Isesaki
State/Province
Gunma
Country
Japan
Facility Name
Nakano Clinic
City
Shibukawa
State/Province
Gunma
Country
Japan
Facility Name
Iryouhoujinn Makikai Makibyouinn
City
Takasaki
State/Province
Gunma
Country
Japan
Facility Name
Shigenobu Clinic
City
Miyoshi
State/Province
Hiroshima
Country
Japan
Facility Name
Keiyukai Yoshida Hospital
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Matsui Naika Clinic
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Omiya Clinic
City
Asahikawa
State/Province
Hokkaido
Country
Japan
Facility Name
Miyanomori Memorial Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Okamoto Naika Clinic
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
River Side Clinic
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Katsuya Iin
City
Amagasaki
State/Province
Hyogo
Country
Japan
Facility Name
Kousei Hospital
City
Himeji
State/Province
Hyogo
Country
Japan
Facility Name
Nakatani Hospital
City
Himeji
State/Province
Hyogo
Country
Japan
Facility Name
Harima Clinic
City
Kakogawa
State/Province
Hyogo
Country
Japan
Facility Name
Kusunose Surgery Clinic
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Yamaki Medical Clinic
City
Hitachinaka
State/Province
Ibaraki
Country
Japan
Facility Name
Shika Clinic
City
Hakui
State/Province
Ishikawa
Country
Japan
Facility Name
Yanagi Medical Clinic
City
Hakusan
State/Province
Ishikawa
Country
Japan
Facility Name
Kakuda Iin
City
Kahoku
State/Province
Ishikawa
Country
Japan
Facility Name
Dr Hayakawa's Family Clinic
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Wakasa Medical Clinic
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Okyozuka Clinic
City
Nonoichi
State/Province
Ishikawa
Country
Japan
Facility Name
Matsuoka Clinic
City
Takamatsu
State/Province
Kagawa
Country
Japan
Facility Name
Ori Clinic
City
Ashigarakami
State/Province
Kanagawa
Country
Japan
Facility Name
Iroden Clinic
City
Kamakura
State/Province
Kanagawa
Country
Japan
Facility Name
Nagasu Clinic
City
Kamakura
State/Province
Kanagawa
Country
Japan
Facility Name
Shohei Clinic
City
Kamakura
State/Province
Kanagawa
Country
Japan
Facility Name
Kamegaya Clinic
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Kobayashi Hospital
City
Odawara
State/Province
Kanagawa
Country
Japan
Facility Name
Hakuai Iin
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Yamamoto Clinic
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
International Goodwill Hospital
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Kikuchi Clinic
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Shimokurata Heart Clinic
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Tani Clinic Internal Medicine, Allergology & Rheumatology
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Tsurumi Chuo Clinic
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Yamagami Naika
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Yokohama Sotetsu bldg Clinic of Internal Medicine
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Toihata Naika
City
Aso
State/Province
Kumamoto
Country
Japan
Facility Name
Omori Iin
City
Koshi
State/Province
Kumamoto
Country
Japan
Facility Name
Kan Kaimeido Clinic
City
Tamana
State/Province
Kumamoto
Country
Japan
Facility Name
Matsuo Clinic
City
Tamana
State/Province
Kumamoto
Country
Japan
Facility Name
Miyagi clinic cardiovascular medicine
City
Yatsushiro
State/Province
Kumamoto
Country
Japan
Facility Name
Iwasaki Hospital
City
Tsu
State/Province
Mie
Country
Japan
Facility Name
Eto Clinic
City
Nichinan
State/Province
Miyazaki
Country
Japan
Facility Name
Kawano Clinic
City
Nichinan
State/Province
Miyazaki
Country
Japan
Facility Name
Miyata Naika Iin
City
Nobeoka
State/Province
Miyazaki
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
State/Province
Nara
Country
Japan
Facility Name
Ote Clinic of Internal
City
Sakurai
State/Province
Nara
Country
Japan
Facility Name
Uchiyama Clinic
City
Joetsu
State/Province
Niigata
Country
Japan
Facility Name
Hospital, University of the Ryukyus
City
Nakagami
State/Province
Okinawa
Country
Japan
Facility Name
Nishimura Clinic
City
Fujiidera
State/Province
Osaka
Country
Japan
Facility Name
Ikeda Clinic
City
Higashiosaka
State/Province
Osaka
Country
Japan
Facility Name
Kanazawa Clinic
City
Izumi
State/Province
Osaka
Country
Japan
Facility Name
Hayashi Medical Clinic
City
Sakai
State/Province
Osaka
Country
Japan
Facility Name
Matsuo Clinic
City
Yao
State/Province
Osaka
Country
Japan
Facility Name
Enomoto Clinic
City
Ageo
State/Province
Saitama
Country
Japan
Facility Name
Saitama Medical Center
City
Kawagoe
State/Province
Saitama
Country
Japan
Facility Name
Iryohojin Hogi sinryojyo
City
Kawaguchi
State/Province
Saitama
Country
Japan
Facility Name
Okuaki Clinic
City
Kawaguchi
State/Province
Saitama
Country
Japan
Facility Name
Tokutake Iin
City
Kawaguchi
State/Province
Saitama
Country
Japan
Facility Name
Medical Corporation Shibuya Clinic
City
Kumagaya
State/Province
Saitama
Country
Japan
Facility Name
Ota Clinic
City
Awa
State/Province
Tokushima
Country
Japan
Facility Name
Minami National Health Insurance Hospital Of Minami Town
City
Kaifu-gun
State/Province
Tokushima
Country
Japan
Facility Name
Sekishinkan Hospital
City
Komatsushima
State/Province
Tokushima
Country
Japan
Facility Name
Tanaka Clinic
City
Myozai-gun
State/Province
Tokushima
Country
Japan
Facility Name
Harada Clinic
City
Adachi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Johoku Clinic
City
Adachi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Moritani Clinic
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Nishimura Memorial Hospital
City
Edogawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Hosoda-Clinic
City
Katsushika-ku
State/Province
Tokyo
Country
Japan
Facility Name
Okuda clinic
City
Kita-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tenjinmae Clinic
City
Mitaka
State/Province
Tokyo
Country
Japan
Facility Name
Daiba Shinryojo
City
Nakano-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kurumatani Clinic
City
Nerima-ku
State/Province
Tokyo
Country
Japan
Facility Name
Oono Iin
City
Nerima-ku
State/Province
Tokyo
Country
Japan
Facility Name
Sugawara Clinic
City
Nerima-ku
State/Province
Tokyo
Country
Japan
Facility Name
Baba Iin
City
Nishitokyo
State/Province
Tokyo
Country
Japan
Facility Name
Miyahara Clinic
City
Ota-ku
State/Province
Tokyo
Country
Japan
Facility Name
Taguchi Clinic
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kobayashi Clinic
City
Suginami-ku
State/Province
Tokyo
Country
Japan
Facility Name
Tominaga Clinic
City
Tachikawa
State/Province
Tokyo
Country
Japan
Facility Name
Kirino Clinic
City
Toshima-ku
State/Province
Tokyo
Country
Japan
Facility Name
Yamada Clinic
City
Toshima-ku
State/Province
Tokyo
Country
Japan
Facility Name
Ayame Medical Clinic
City
Shimonoseki
State/Province
Yamaguchi
Country
Japan
Facility Name
Matuda Clinic
City
Shimonoseki
State/Province
Yamaguchi
Country
Japan
Facility Name
Kuroda Iin
City
Otsuki city
State/Province
Yamanashi pref.
ZIP/Postal Code
409-0614
Country
Japan
Facility Name
Saku Hospital
City
Fukuoka
Country
Japan
Facility Name
Tohaya Iin
City
Fukuoka
Country
Japan
Facility Name
Iryohojin Shadan Seijinkai Kawade Iin
City
Gifu
Country
Japan
Facility Name
Kawai Naika Clinic
City
Gifu
Country
Japan
Facility Name
Miwa Clinic: Gastroenterology Hepatology
City
Gifu
Country
Japan
Facility Name
Sagou Clinic
City
Gifu
Country
Japan
Facility Name
Sasaki Clinic
City
Gifu
Country
Japan
Facility Name
Takai Clinic
City
Gifu
Country
Japan
Facility Name
Takeda Clinic
City
Gifu
Country
Japan
Facility Name
Totani Medical Clinic
City
Gifu
Country
Japan
Facility Name
Shimamoto Hospital
City
Kochi
Country
Japan
Facility Name
Honjo Internal Medicine Hospital
City
Kumamoto
Country
Japan
Facility Name
Jinnouchi Clinic Diabetes Care Center
City
Kumamoto
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
Country
Japan
Facility Name
Maki Cardiovascular Clinic
City
Kumamoto
Country
Japan
Facility Name
Otsuka Hospital
City
Kumamoto
Country
Japan
Facility Name
Suizenji Touya Hospital
City
Kumamoto
Country
Japan
Facility Name
TERAO Hospital
City
Kumamoto
Country
Japan
Facility Name
Isoda Internal Medical Clinic
City
Kyoto
Country
Japan
Facility Name
Koseikai Clinic
City
Kyoto
Country
Japan
Facility Name
Takenaka Clinic
City
Kyoto
Country
Japan
Facility Name
Yokota Naika
City
Miyazaki
Country
Japan
Facility Name
Maeda Medical Clinic
City
Niigata
Country
Japan
Facility Name
Akioka Clinic
City
Osaka
Country
Japan
Facility Name
Kinugawa Cardiology Clinic
City
Osaka
Country
Japan
Facility Name
Kondo Clinic
City
Osaka
Country
Japan
Facility Name
Kubota Clinic
City
Osaka
Country
Japan
Facility Name
Matsushita Medical Clinic
City
Osaka
Country
Japan
Facility Name
Nanko Clinic
City
Osaka
Country
Japan
Facility Name
Seo Heart Clinic
City
Osaka
Country
Japan
Facility Name
Watanabe Iin
City
Osaka
Country
Japan
Facility Name
Harada Medical Clinic
City
Shizuoka
Country
Japan
Facility Name
Shizuoka Municipal Hospital
City
Shizuoka
Country
Japan
Facility Name
Waki Riichiro Clinic
City
Shizuoka
Country
Japan
Facility Name
Itsumo Smile Clinic
City
Tokushima
Country
Japan
Facility Name
Shimasaki Clinic
City
Yamagata
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
35648242
Citation
Kojima S, Uchiyama K, Yokota N, Tokutake E, Wakasa Y, Hiramitsu S, Waki M, Jinnouchi H, Kakuda H, Hayashi T, Kawai N, Sugawara M, Mori H, Tsujita K, Matsui K, Hisatome I, Ohya Y, Kimura K, Saito Y, Ogawa H; Febuxostat for Cerebral and CaRdiorenovascular Events PrEvEntion StuDy (FREED) investigators. C-reactive Protein Levels and Cardiovascular Outcomes After Febuxostat Treatment in Patients with Asymptomatic Hyperuricemia: Post-hoc Analysis of a Randomized Controlled Study. Cardiovasc Drugs Ther. 2023 Oct;37(5):965-974. doi: 10.1007/s10557-022-07347-7. Epub 2022 Jun 1.
Results Reference
derived
PubMed Identifier
34605897
Citation
Kojima S, Uchiyama K, Yokota N, Tokutake E, Wakasa Y, Hiramitsu S, Waki M, Jinnouchi H, Kakuda H, Hayashi T, Kawai N, Sugawara M, Mori H, Tsujita K, Matsui K, Hisatome I, Ohya Y, Kimura K, Saito Y, Ogawa H; Febuxostat for Cerebral and Cardiorenovascular Events Prevention Study (FREED) investigators. Optimal uric acid levels by febuxostat treatment and cerebral, cardiorenovascular risks: post hoc analysis of a randomized controlled trial. Rheumatology (Oxford). 2022 May 30;61(6):2346-2359. doi: 10.1093/rheumatology/keab739.
Results Reference
derived
PubMed Identifier
30844048
Citation
Kojima S, Matsui K, Hiramitsu S, Hisatome I, Waki M, Uchiyama K, Yokota N, Tokutake E, Wakasa Y, Jinnouchi H, Kakuda H, Hayashi T, Kawai N, Mori H, Sugawara M, Ohya Y, Kimura K, Saito Y, Ogawa H. Febuxostat for Cerebral and CaRdiorenovascular Events PrEvEntion StuDy. Eur Heart J. 2019 Jun 7;40(22):1778-1786. doi: 10.1093/eurheartj/ehz119.
Results Reference
derived
PubMed Identifier
27005768
Citation
Kojima S, Matsui K, Ogawa H, Jinnouchi H, Hiramitsu S, Hayashi T, Yokota N, Kawai N, Tokutake E, Uchiyama K, Sugawara M, Kakuda H, Wakasa Y, Mori H, Hisatome I, Waki M, Ohya Y, Kimura K, Saito Y; Febuxostat for Cerebral and Cardiorenovascular Events Prevention Study (FREED) investigators. Rationale, design, and baseline characteristics of a study to evaluate the effect of febuxostat in preventing cerebral, cardiovascular, and renal events in patients with hyperuricemia. J Cardiol. 2017 Jan;69(1):169-175. doi: 10.1016/j.jjcc.2016.02.015. Epub 2016 Apr 20.
Results Reference
derived

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Febuxostat for Cerebral and caRdiorenovascular Events prEvEntion stuDy

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