UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001548 |
|---|---|
| Receipt number | R000001868 |
| Scientific Title | The Evaluation of Effects against Acute- or Relapse Infarction in Patients with both Diabetes and Hypertension Taking ARB and PPAR-gammma Inhibitor |
| Date of disclosure of the study information | 2008/12/03 |
| Last modified on | 2019/02/26 09:53:19 |
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Basic information
Public title
The Evaluation of Effects against Acute- or Relapse Infarction in Patients with both Diabetes and Hypertension Taking ARB and PPAR-gammma Inhibitor
Acronym
The Evaluation of Effects against Acute- or Relapse Infarction in Patients with both Diabetes and Hypertension Taking ARB and PPAR-gamma Inhibitor (ARITA Study)
Scientific Title
The Evaluation of Effects against Acute- or Relapse Infarction in Patients with both Diabetes and Hypertension Taking ARB and PPAR-gammma Inhibitor
Scientific Title:Acronym
The Evaluation of Effects against Acute- or Relapse Infarction in Patients with both Diabetes and Hypertension Taking ARB and PPAR-gamma Inhibitor (ARITA Study)
Region
| Japan |
Condition
Condition
Patients with diabetes and hypertension
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of pioglitazone hydrochloride against the acute- or relapse infarction, the cardiac depression, and the impairing renal function for patients with both diabetes and essential hypertension, the patients are followed up for 3 years taking pioglitazone hydrochloride or sulfonylurea hypoglycemic agent on stable depressor therapy.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary end-point is time from randomization to first occurrence of any of the events in the following composite:
1. Cardiovascular disturbance
2. Cerebrovascular disease
3. Renal failure
4. Administration of dialysis treatment
5. Cardiac mortality
6. Cerebrovascular mortality
Key secondary outcomes
Secondary end-point is time from randomization to first occurrence of any of the events in the following composite:
1. All-cause mortality
2. Cardiac depression and impairing renal function
3. Progression of diabetes
4. Progression of hypertension
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
In the thiazolidine derivatives group, thiazolidine derivatives will be prescribed as per specifications attached.
Interventions/Control_2
In sulfonylurea hypoglycemic agent, the agent will be prescribed as per specifications attached.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient with both diabetes and essential hypertension or patient undergoing treatment of antihypertensive agent who is newly taking diabetic medicine
Key exclusion criteria
1) History of cardiac failure
2) Diagnosis of Cardiovascular disturbance and/or cerebrovascular disease within 6 months
3) Secondary hypertension
4) Type I diabetes
5) Diagnosis and/or treatment of cancer within 5 years
6) Renal dysfunction
7) Liver dysfunction
8) History of side effects of TDZ or ARB
9) No current or past history of psychiatric disorders
10) Pregnant women or lactating mothers
11) Participating another clinical investigation within 3 months
12) Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Inoue |
Organization
Imari Arita Kyoritsu Hospital.
Division name
Department of Surgery
Zip code
Address
860 Ninosekou, Arita, Nishimatsuura, Saga
TEL
0955-46-2121
ikyoku@imari-arita-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Koezuka |
Organization
HuBit genomix, Inc.
Division name
Research & Development Department
Zip code
Address
7-10-2 Tsukiji, Chuo-Ku, Tokyo
TEL
03-5148-3992
Homepage URL
ykoezuka@hubitgenomix.com
Sponsor or person
Institute
HuBit genomix, Inc.
Institute
Department
Personal name
Funding Source
Organization
Japan Heart Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cerebral and Cardiovascular Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 03 | Day |
Last modified on
| 2019 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001868
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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