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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000328
Receipt No. 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

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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
Email

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
Email yishigaki@int3.tohoku.ac.jp

Sponsor
Institute Dyslipidemia with diabetes study group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000390

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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