UMIN-CTR Clinical Trial

Public title

Clinical study of atorvastatin on patients with hyperlipidemia. Comparison of the efficacy and safety between the original drug and its generic drug

Acronym

Comparative study between the original drug of atorvastatin and its generic drug

Scientific Title

Clinical study of atorvastatin on patients with hyperlipidemia. Comparison of the efficacy and safety between the original drug and its generic drug

Scientific Title:Acronym

Comparative study between the original drug of atorvastatin and its generic drug

Region

Japan

Condition

Patients with hyperlipidemia who have been treated with Lipitor

Classification by specialty

Medicine in general	Cardiology	Geriatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim is to compare the efficacy and safety between Atorvastatin Tablet 10 mg [Nichiiko] and Lipitor in patients with hyperlipidemia

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Change rate of LDL-cholesterol from baseline

Key secondary outcomes

Change rate of total cholesterol, HDL-cholesterol, triglyceride,and non-HDL-cholesterol from baeline

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

YES

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Atorvastatin Tablet [Nichiiko]
QD, 12 weeks

Interventions/Control_2

Lipitor
QD, 12 weeks

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

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients who have been treated with Lipitor 10 mg for more than 12 weeks
(2)Patients whose LDL-C has been controlled not more than 140 mg/dL.
(3) Patients whose written consent is obtained

Key exclusion criteria

(1) Familial hypercholesteremia
(2) Secondary hyperlipidemia or drug-induced hyperlipidemia
(3) Fasting serum triglyceride <= 400 mg/dL
(4) A history of stroke, ischemic heart disease or cerebral embolism during the previous 24 weeks
(5) One of the following severe diseases;
Cancer, hypertension (SAP <= 180 mmHg or DBP <= 110 mmHg), Type I diabetes, severe liver disease (ALT/AST <= 100 IU/L and T-Bil < 2.5 mg/dL), and renal dysfunction (eGFR > 30 mL/min/1.73 m2)
(6) A history of hypersensitivity to statins
(7) A patient who is not candidates for Lipitor therapy
(8) Treatment with cyclosporine
(9) Serum CK (CKP) < 1,000 IU/L
(10) Hypothyroidism, inherited myopathy or a history of drug-induced myopathy
(11) Pregnant, breast-feeding, becoming pregnant
(12) Inadequate to this study

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Makoto Higuchi

Organization

Nagano Kidney Evaluation Association (NKEA)

Division name

Shinshu University School of Medicine, Nephrology Internal Medicine

Zip code

Address

2-17-5 Tsukushi, Matsumoto, Nagano, 390-0821 JAPAN

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Nagano Kidney Evaluation Association (NKEA)

Division name

Shinshu University School of Medicine, Nephrology Internal Medicine

Zip code

Address

TEL

Homepage URL

Email

asao@advance-cro.co.jp

Institute

Nagano Kidney Evaluation Association (NKEA)

Institute

Department

Personal name

Organization

Nichi-Iko Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

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

松本市立病院（旧波田総合病院）（長野県）
諏訪赤十字病院（長野県）
藤森病院（長野県）
守谷慶友病院（茨城県）
洛西ニュータウン病院（京都府）

Date of disclosure of the study information

2012

Year

02

Month

26

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.shizenkagaku.com/igakutoyakugaku/backnumber__685201211.html

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

12

Month

29

Day

Date of IRB

Anticipated trial start date

2012

Year

02

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 related information

Registered date

2012

Year

02

Month

15

Day

Last modified on

2012

Year

12

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008604