UMIN-CTR Clinical Trial

Public title

Practical combination therapy of Amlodin and angiotensin II Receptor blocker(ARB); safety and efficacy in paTieNts with hypERtension Study (PARTNER Study)

Acronym

PARTNER Study

Scientific Title

Practical combination therapy of Amlodin and angiotensin II Receptor blocker(ARB); safety and efficacy in paTieNts with hypERtension Study (PARTNER Study)

Scientific Title:Acronym

PARTNER Study

Region

Japan

Condition

Hypertension

Classification by specialty

Medicine in general	Cardiology	Endocrinology and Metabolism
Geriatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the safety and efficacy of combination Amlodin and angiotensin II Receptor blocker(ARB) for hypertension in daily clinical settings
The case study of the 10mg Amlodin investigates the efficacy and safety of patient doses

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[Safety]
The incidence of side effects(Primary endpoint)
The incidences of serious adverse events
[Efficacy]
Change in blood pressure in the doctor's office(Primary endpoint)
Defining the percentage of cases who achieved the guideline-oriented hypertensive treatment goal(Guideline for the management of hypertension 2009 established by The Japanese Society of Hypertension)
[Other]
Renal function

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects those who must satisfy the following conditions
(1)Amlodin-naive-hypertensive patients who have been receiving antihypertensive therapy with ARB
(2)ARB-naive-hypertensive patients who have been receiving antihypertensive therapy with Amlodin
(3)Amlodin and ARB-naive-hypertensive patients

Key exclusion criteria

(1)Hypertensive Patients who had already received antihypertensive combination therapy with both Amlodin and ARB,and ARB-amlodipine combination agent, before the enrollment
(2)Hypertensive patients who have received amlodipine preparation except Amlodin within 12 weeks of the enrollment

Target sample size

6000

Name of lead principal investigator

1st name
Middle name
Last name	Toshihiko Ishimitsu

Organization

Dokkyo Medical University School of Medicine

Division name

Division of Cardiovascular Medicine

Zip code

Address

880,Kitakobayashi,MIbu-machi, Shimotsuga-gun,Tochigi,329-0498, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Hirofumi Fukuda

Organization

Dainippon Sumitomo Pharma Co.,Ltd.

Division name

Post Marketing Surveillance Department

Zip code

Address

1-5-51,Ebie,Fukushima-ku,Osaka,553-0001,Japan

TEL

06-6454-8113

Homepage URL

Email

hirofumi-1-fukuda@ds-pharma.co.jp

Institute

Dainippon Sumitomo Pharma Co.,Ltd.

Institute

Department

Personal name

Organization

Dainippon Sumitomo Pharma 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

2011

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Partially published

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

02

Month

24

Day

Date of IRB

Anticipated trial start date

2011

Year

07

Month

01

Day

Last follow-up date

2013

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1)Patients background and constitution
2)Safety
The incidence of side effects(Primary endpoint)
The incidences of serious adverse events
To idetify possible factors which contribute the incidence of side effects
3)Efficacy
Change in blood pressure in the doctor's office(Primary endpoint)
Defining the percentage of cases who achieved the guideline-oriented hypertensive treatment goal(Guideline for the management of hypertension 2009 established by The Japanese Society of Hypertension)
factors which contribute the change in office blood pressure
4)Other
Renal function

Registered date

2011

Year

06

Month

30

Day

Last modified on

2013

Year

07

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006954