UMIN-CTR Clinical Trial

Public title

Investigation oflipid-improving and pleiotrophic effects of pitavastatin

Acronym

Investigation oflipid-improving and pleiotrophic effects of pitavastatin

Scientific Title

Investigation oflipid-improving and pleiotrophic effects of pitavastatin

Scientific Title:Acronym

Investigation oflipid-improving and pleiotrophic effects of pitavastatin

Region

Japan

Condition

Hpercholesterolemic patients with type II diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate influences of statin on lipid profiles, inflammation and oxidative stress in hypercholesterolemic patients with type II diabetes

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Amounts and percentages of canges in the following factors after 3-, 6-, and 12-month treatment
1) Changes in LDL and HDL suclasses and
CETP
2) Changes in urinary LFABP
3) Changes in serum hs-CRP

Key secondary outcomes

1. Amounts and pecentages of changes in following factors after 3-, 6-, and 12-month treatment
1)Serum lipid profile (TC,LDL-C, HDL-C, TG)
2) serum CETP
3) serum apolipoprotein A1,
4) serum adiponectin,
5) urinary albumin to
creatinine ratio
6) urinary VEGF-(A, C)

2. Association analyses between percentage changes in subclasses of LDL or HDL and pretreatment levels of clinical factor

3. Association analyses between percentage changes in subclasses of LDL or HDL and

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pitavastatin 2mg, onece daily for 6 months

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients who
1)are aged betwenn 20 and 80 years at time of consent and male or female
2)are mild diabetes mellitus by HbA1c < 8.4% (NGSP)
3)have Hypercholesterolemia with serum LDL-C levels of 120mg/dL or more or serum TC levels of 220mg/dl or more at baseline
4)provide written informed concent for participation in the study

Key exclusion criteria

1) Patients with severe hepatic dysfunction
2) Patients with severe chronic renal dysfunction(serum Cr of 2.0 mg/dL or more)
3) Patients with severe cerebral vascular disease
4)Patients are judged as being inappropriate for this study by their own doctors
5) Patients are judged as being inappropriate for this study by investigators

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Hideki Kimura

Organization

University of Fukui Hospital

Division name

Department of Clinical Laboratory

Zip code

Address

23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida, Fukui, Japan

TEL

+81-776-61-3111

Email

hkimura@u-fukui.ac.jp

Name of contact person

1st name
Middle name
Last name	Hideki Kimura

Organization

University of Fukui Hospital

Division name

Department of Clinical Laboratory

Zip code

Address

23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida, Fukui, Japan

TEL

+81-776-61-3111

Homepage URL

Email

hkimura@u-fukui.ac.jp

Institute

Fukui University School of Medical Science

Institute

Department

Personal name

Organization

Fukui University School of Medical Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Saiseikai Hospital
Fukui Prefectural Hospital
Yasukawa Hospital
Fukui Chuo Clinic
Tanaka Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福井大学病院(福井県), University of Fukui Hospital (Fukui Prefecture)
福井県済生会病院(福井県), Saiseikai Hospital (Fukui Prefecture)
福井県立病院(福井県), Fukui Prefectural Hospital(Fukui Prefecture)
安川病院(福井県), Yasukawa Hospital(Fukui Prefecture)
福井中央クリニック(福井県), Fukui Chuo Clinic(Fukui Prefecture)
田中病院(福井県), Tanaka Hospital(Fukui Prefecture)

Date of disclosure of the study information

2015

Year

09

Month

15

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

1) The pitavastatin treatment decreased LDL-C, sd-LDL-C, and CETP levels by 39%, 42%, and 23%, respectively.
2) Despite the absence of a significant association between CETP and LDL-C levels at baseline, baseline CETP levels and its percentage change were an independent positive determinant for the changes observed in LDL-C and sd-LDL-C levels.

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

Recruitment status

Completed

Date of protocol fixation

2007

Year

12

Month

05

Day

Date of IRB

Anticipated trial start date

2008

Year

07

Month

15

Day

Last follow-up date

2011

Year

03

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

09

Month

15

Day

Last modified on

2015

Year

09

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021994