UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007904
Receipt number R000009309
Scientific Title Effect of the Alogliptin in hypertensive patients with diabetes using Piogritazon.
Date of disclosure of the study information 2012/05/08
Last modified on 2012/05/09 23:47:02

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Basic information

Public title

Effect of the Alogliptin in hypertensive patients with diabetes using Piogritazon.

Acronym

Effect of the Alogliptin in hypertensive patients with diabetes using Piogritazon.

Scientific Title

Effect of the Alogliptin in hypertensive patients with diabetes using Piogritazon.

Scientific Title:Acronym

Effect of the Alogliptin in hypertensive patients with diabetes using Piogritazon.

Region

Japan


Condition

Condition

Hypertensive diabetic patients

Classification by specialty

Medicine in general Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Compare to the cardioprotection of Alogriptin and increase doses of Piogritazon as combination therapy in hypertensive diabetic patients using Piogritazon.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

One year after,surrogate marker of arterial sclerosis

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

24-week treatment of Alogliptin in combination with Piogritazon

Interventions/Control_2

24-week treatment of increase doses of Piogritazon

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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with type 2 diabetes and hypertension(Age 20-75 years).
Patients on therapy of Piogritazon.
Informed consent obtained .

Key exclusion criteria

Patients on therapy of DPP-4i.
Informed consent cannot be obtained.
Any other condition which the attending physician feels would interfere with the trial participation.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunori Utsunomiya

Organization

Jikei University School of Medicine

Division name

Division of Diabetes and Endocrinology Department of Internal Medicine

Zip code


Address

3-25-8 Nishishinbashi, Minatoku, Tokyo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Jikei University School of Medicine

Division name

Division of Diabetes and Endocrinology Department of Internal Medicine

Zip code


Address

3-25-8 Nishishinbashi, Minatoku, Tokyo, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Other

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

2012 Year 05 Month 08 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

Enrolling by invitation

Date of protocol fixation

2012 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 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

2012 Year 05 Month 08 Day

Last modified on

2012 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009309


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name