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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027224
Receipt No. R000029784
Scientific Title The effects of Teneligliptin on vascular inflammatory markers in post-PCI (Percutaneous Coronary Intervention) patients.
Date of disclosure of the study information 2017/05/02
Last modified on 2018/11/15

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Basic information
Public title The effects of Teneligliptin on vascular inflammatory markers in post-PCI (Percutaneous Coronary Intervention) patients.
Acronym The effects of Teneligliptin on vascular inflammatory markers in post-PCI (Percutaneous Coronary Intervention) patients.
Scientific Title The effects of Teneligliptin on vascular inflammatory markers in post-PCI (Percutaneous Coronary Intervention) patients.
Scientific Title:Acronym The effects of Teneligliptin on vascular inflammatory markers in post-PCI (Percutaneous Coronary Intervention) patients.
Region
Japan

Condition
Condition Coronary Artery Disease
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects of Teneligliptin on vascular inflammatory markers in PCI patients with T2DM (Type 2 diabetes mellitus).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Variation amount and rate of inflammatory markers from pretreatment levels.
Key secondary outcomes Vascular endothelial function: RH-PAT score, variation amount and rate of HbA1c, and glucose from pretreatment levels.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Additional treatment of Teneligliptin
Interventions/Control_2 Conventional treatment
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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Elective PCI patients
2)Patients who have T2DM and HbA1c (NGSP) level are more than 7% before PCI
3)Patients aged 30 up to 80 years old
4)Informed consent was signed by all patients and documented.
Key exclusion criteria 1)Patients with T1DM (type 1 diabetes mellitus)
2)Patients who have medical history of hypersensitivity to diabetes mellitus drugs
3)Patients with medical history of malignant tumor
4)Patients with severe infection, before and after operation, or severe trauma
5)Patients with cardiac arrest (class of III in NYHA)
6)Patients with uncontrolled hypertension 7)Patients with insulin dependent and the potential to change diabetic drugs
8)Patients with severe renal insufficiency
(eGFR is less than 30 mL / min / 1.73 m2, dialysis-dependent, or serum creatinine (men, more than 2.5 mg / dL, women, more than 2.0 mg / dL
9) Patients with pregnant, and possibly pregnant
10) Patients with severe ketosis, diabetic coma, or history of coma within the past six months
11)Patients who had stroke, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack within the past three months.
12)Patients who enrolled into another clinical test within three months prior to this trial
13)Patients who cannot administer antiplatelet drugs
14)Patients who were considered as inappropriate for the study by the investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Matshumura
Organization Kameda Medhical Center
Division name Department of Cardiology
Zip code
Address 929 Higashi-cho Kamogawa City CHiba
TEL 04-7092-2211
Email matsumura.akihiko@kameda.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aya JUNI
Organization AsMediX Co., Ltd.
Division name GPO Department , Business Planning Section
Zip code
Address Higashiazabu 1-5-2, Minato-ku, Tokyo
TEL 03-6230-3661
Homepage URL
Email aya_juni@asmedix.co.jp

Sponsor
Institute Kameda Medhical Center
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 05 Month 02 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
2016 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 02 Day
Last modified on
2018 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029784

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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