UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Evaluation of Effects against Acute- or Relapse Infarction in Patients with both Diabetes and Hypertension Taking ARB and PPAR-gammma Inhibitor
Title of the study (Brief title)	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	Fumio Inoue
Organization	Imari Arita Kyoritsu Hospital.
Division name	Department of Surgery
Address	860 Ninosekou, Arita, Nishimatsuura, Saga
TEL	0955-46-2121
Email	ikyoku@imari-arita-hp.or.jp

Public contact
Name of contact person	Yasuhiko Koezuka
Organization	HuBit genomix, Inc.
Division name	Research & Development Department
Address	7-10-2 Tsukiji, Chuo-Ku, Tokyo
TEL	03-5148-3992
Homepage URL
Email	ykoezuka@hubitgenomix.com

Sponsor
Institute	HuBit genomix, Inc.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 01 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001868