UMIN-CTR Clinical Trial

Public title

A clinical study of amlodipine besilate OD tablet for the essential hypertension patients
- Comparative study on the antihypertensive effect and the safety between a bland drug and a generic drug -

Acronym

A comparative study on the efficacy and safety between a bland drug and a generic drug of the amlodipine besilate OD tablet

Scientific Title

A clinical study of amlodipine besilate OD tablet for the essential hypertension patients
- Comparative study on the antihypertensive effect and the safety between a bland drug and a generic drug -

Scientific Title:Acronym

A comparative study on the efficacy and safety between a bland drug and a generic drug of the amlodipine besilate OD tablet

Region

Japan

Condition

Essential hypertension

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Randomized, open-label, and comparative study on the antihypertensive effect and safety between a bland drug and a generic drug of the amlodipine besilate OD tablet in essential hypertension patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change of diastolic blood pressure from baseline in trough and sitting position

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

amlodipine besilate OD tablet (a generic drug)
2.5 mg or 5 mg

Interventions/Control_2

amlodipine besilate OD tablet (a bland drug)
2.5 mg or 5 mg

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.Essential hypertension Grade I and II patients diagnosed according to the Hypertension Treatment Guideline 2009 of the Japanese Society of Hypertension
2.Patients who have been taking amlodipine besilate regular tablets (2.5 or 5 mg, single daily) for more than 8 weeks
3.Patients whose diastolic blood pressure has been kept between >=70 mmHg and <110 mmHg for 2 months
4.Patients whose written consent is obtained at age 20 years or over, etc

Key exclusion criteria

1.Patients who take calcium channel blocker except amlodipine besilate regular tablets
2.Grade III hypertension
3.Secondary hypertension
4.Malignant hypertension
5.Patients with hepatic dysfunction or severe hepatic disease
6.Patients with a past history of hypersensitiveness to the study drug
7.Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant during the study period
8.Patients with malignant cancer
9.Patients with a past history of drug abuse or drug addiction
10.Patients who have attended toany clinical trials within 12 months before the start of the administration, etc

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

Nephrology Internal Medicine, Shinshu University School of Medicine

Zip code

Address

3-1-1 Asahi, Matsumoto, Nagano, 390-8621 JAPAN

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Nagano Kidney Evaluation Association (NKEA)

Division name

Nephrology Internal Medicine, Shinshu University School of Medicine

Zip code

Address

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

TEL

Homepage URL

Email

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

Date of disclosure of the study information

2009

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

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

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

2009

Year

05

Month

15

Day

Date of IRB

Anticipated trial start date

2009

Year

07

Month

01

Day

Last follow-up date

2009

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

06

Month

30

Day

Last modified on

2009

Year

12

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002619