UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000328 |
|---|---|
| Receipt number | R000000390 |
| Scientific Title | Nippon Medical School- Tohoku University Graduate School Intervention with Pitavastatin: Study for hypercholesterolemia with type 2 diabetes mellitus. |
| Date of disclosure of the study information | 2006/03/01 |
| Last modified on | 2008/02/19 23:02:04 |
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Basic information
Public title
Nippon Medical School- Tohoku University Graduate School Intervention with Pitavastatin: Study for hypercholesterolemia with type 2 diabetes mellitus.
Acronym
Nippon medical school, Tohoku university, Plaque Prevention study (NTPP study)
Scientific Title
Nippon Medical School- Tohoku University Graduate School Intervention with Pitavastatin: Study for hypercholesterolemia with type 2 diabetes mellitus.
Scientific Title:Acronym
Nippon medical school, Tohoku university, Plaque Prevention study (NTPP study)
Region
| Japan |
Condition
Condition
Hypercholesterolemic patients with type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and the efficacy of Pitavastatin on the prevention of atherosclerosis in hypercholesterolemic patients with type2 diabetes mellitus.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A change of intima-media thickness (IMT)of common carotid artery
Key secondary outcomes
A change of the following items
(1)Serum lipid profile (LDL-C, triglyceride, HDL-C)
(2)Atherosclerosis-related markers (adiponectin, hsCRP, PCOOH, urinary 8-OH-dG)
(3)LPL mass
(4)Plasma glucose (fasting plasma glucose, HbA1c)
(5)Microalbuminuria
Evaluation of adverse events and laboratory test abnormalities
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pitavastatin 1 mg or 2 mg daily for a period of 36 months
Interventions/Control_2
Pravastatin 10 mg daily for a period of 36 months
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 who
(1)are treated with diet, exercise and/or medication for at least 8 weeks, with HbA1c < 8.0% (a percent change to be =/< +/-10%) at last 2 measurements.
(2)have Hypercholesterolemia with fasting level of serum LDL-C >/= 140 mg/dL (by the Friedewald formula) at measurements in the run-in period.
(3)have fasting serum levels of triglyceride < 400 mg/dL.
(4)are diagnosed with type 2 diabetes.
(5)are at age of 20 to 75 years at time of consent.
(6)male or female
(7)provide written informed concent for participation in the study voluntarily after being fully informed and explained.
Key exclusion criteria
(1)Uncontrolled diabetes mellitus (HbA1c >/= 8.0%).
(2)Known hypersensitivity or history of clinically significant adverse reactions to any component of drugs.
(3)Have serious hypertension (systolic blood pressure >/= 180 mmHg, or diastolic blood pressure >/= 110 mmHg)
(4)History of stroke, myocardial infarction (observed within the immediate 3 months prior to screening) or heart failure.
(5)Patients with serious renal disfunction or serum creatinine more than 1.5 mg/dL.
(6)Patients who are relevant to contraindications listed in statin labellings.
* Patients with serious liver dysfunction or biliary obstruction.
* Patients who are being treated with cyclosporine.
* Pregnant, possibly pregnant, or lactating.
* Patients, taking fibrates, with laboratory test abnormalities in renal function.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitomo Oka |
Organization
Tohoku University, Graduate School of Medicine
Division name
Molecular Metabolism and Diabetes
Zip code
Address
2-1, SEIRYO-CHO, AOBAKU, SENDAI, MIYAGI 980-8575
TEL
022-717-7611
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Ishigaki |
Organization
Dyslipidemia with diabetes study group
Division name
Molecular Metabolism and Diabetes, Tohoku University, Graduate School of Medicine
Zip code
Address
2-1, SEIRYO-CHO, AOBAKU, SENDAI, MIYAGI 980-8575
TEL
022-717-7611
Homepage URL
yishigaki@int3.tohoku.ac.jp
Sponsor or person
Institute
Dyslipidemia with diabetes study group
Institute
Department
Personal name
Funding Source
Organization
Dyslipidemia with diabetes study group
Organization
Division
Category of Funding Organization
Self funding
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
| 2006 | Year | 03 | Month | 01 | 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
Date of protocol fixation
| 2005 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | 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
| 2006 | Year | 02 | Month | 07 | Day |
Last modified on
| 2008 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000390
