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
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
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
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
