UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013213
Receipt number R000015416
Scientific Title Effect of on combination therapy with irbesartan and amlodipine besilate on clinical blood pressure, home blood pressure and blood pressure variability in hypertensive patients with chronic kidney disease
Date of disclosure of the study information 2014/02/21
Last modified on 2014/02/21 14:17:02

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Basic information

Public title

Effect of on combination therapy with irbesartan and amlodipine besilate on clinical blood pressure, home blood pressure and blood pressure variability in hypertensive patients with chronic kidney disease

Acronym

Effect of combination therapy with irbesartan and amlodipine besilate on hypertensive patients with chronic kidney disease

Scientific Title

Effect of on combination therapy with irbesartan and amlodipine besilate on clinical blood pressure, home blood pressure and blood pressure variability in hypertensive patients with chronic kidney disease

Scientific Title:Acronym

Effect of combination therapy with irbesartan and amlodipine besilate on hypertensive patients with chronic kidney disease

Region

Japan


Condition

Condition

Hypertension with chronic kidney disease (CKD G1-G4)

Classification by specialty

Medicine in general Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aim to elucidate the effect of combination therapy with long-acting calcium channel blocker amlodipine besilate and long-acting AT1 receptor blocker irbesartan in hypertensive patients with chronic kidney disease. Especially, we evaluate clinical blood pressure, home blood pressure and blood pressure variability.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficacy: Change in the following from baseline to Week 4,8,12:
-Clinical blood pressure, within visit blood pressure variability
-Home blood pressure, home blood pressure variability
-Nighttime blood pressure, nighttime blood pressure variability

Efficacy: Change in the following from baseline to Week 12:
-Body weight, obesity, abdominal circumference
-Laboratory parameters (renal function, oxidative stress etc.)
-Vascular function (AI, ABI/PWV, CAVI)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Irbesartan / amlodipine besilate combination tablets

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) CKD G1-G4.
2) Under the antihypertensive therapy (standard doses of RAS inhibitor or Calcium channel blocker).
3) Blood pressure at hospital visit: Systolic blood pressure is 130 mmHg or higher, or diastolic blood pressure is 80 mmHg or higher.

Key exclusion criteria

1) CKD G5 or dialysis patients.
2) Patients who have allergy for amlodipine besilate or irbesartan.
3) Patients who are pregnant.
4) Patients judged as inappropriate for the study.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kouichi Tamura

Organization

Yokohama City University School of Medicine

Division name

Department of Cadiorenal Medicine

Zip code


Address

3-9 Fukuura Kanazawa-ku, Yokohama 236-0004, Japan

TEL

045-787-2635

Email

tamukou@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kouichi Tamura

Organization

Yokohama City University School of Medicine

Division name

Department of Cadiorenal Medicine

Zip code


Address

3-9 Fukuura Kanazawa-ku, Yokohama 236-0004, Japan

TEL

045-787-2635

Homepage URL


Email

tamukou@med.yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN


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

横浜市立大学附属病院


Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 21 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

Open public recruiting

Date of protocol fixation

2013 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 01 Day

Last follow-up date

2018 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 02 Month 21 Day

Last modified on

2014 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015416


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name