UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004834 |
|---|---|
| Receipt number | R000005756 |
| Scientific Title | Collaborative study for HyperglycemIc patients by Pitavastatin INtervention |
| Date of disclosure of the study information | 2011/01/07 |
| Last modified on | 2013/01/07 13:22:56 |
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Basic information
Public title
Collaborative study for HyperglycemIc patients by Pitavastatin INtervention
Acronym
Collaborative study for HyperglycemIc patients by Pitavastatin INtervention(CHIP-IN)
Scientific Title
Collaborative study for HyperglycemIc patients by Pitavastatin INtervention
Scientific Title:Acronym
Collaborative study for HyperglycemIc patients by Pitavastatin INtervention(CHIP-IN)
Region
| Japan |
Condition
Condition
Hypercholesterolemiac patients with diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of pitavastatin added on to sitagliptin on HbA1c in hypercholesterolemic patients with diabetes mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of HbA1c from the baseline to 24 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Sitagliptin + Pitavastatin
Interventions/Control_2
Sitagliptin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hypercholesterolemic patients with diabetes mellitus with diabetes mellitus
(1) Patients who has administered sitagliptin for more than 12 weeks
(2) Patients whose HbA1c is stable between 5.8% and 8.0% during 12-week sitagliptin therapy
(3) Patients whose LDL-C is between 120 mg/dL and 160 mg/dL
(4) Patients who voluntarily provide informed consent with sufficient comprehension after receiving sufficient explanation of this study
Key exclusion criteria
(1) Patients under insulin treatment
(2) Patients with history of cardiovascular events (ischemic heart disease, cerebral vascular disease, etc.)
(3) CK (CPK) > upper limit of normal (ULN)
(4) AST (GOT) and ALT (GPT) > 3 times ULN
(5) Serum creatinine > 1.5 mg/dL for male, 1.3 mg/dL for female, eGFR < 50 ml/min/1.73 m2
(6) Patients judged to be inappropriate for this study by the investigators
(7) Under 20 years old
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Suzuki |
Organization
Chu-NET
Division name
Owariasahi Clinic
Zip code
Address
2505-1 Harada, Higashi-daido-cho, Owariasahi, Aichi 488-0801, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chu-NET
Division name
Office
Zip code
Address
TEL
Homepage URL
chunet-office@umin.ac.jp
Sponsor or person
Institute
Chu-NET
Institute
Department
Personal name
Funding Source
Organization
Kowa Company, Ltd.
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
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
| 2011 | Year | 01 | Month | 07 | 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
| 2010 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 06 | Day |
Last modified on
| 2013 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005756
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
