UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013460
Receipt number R000015717
Scientific Title Efficacy and safety of Exforge and Aimix in hypertensives
Date of disclosure of the study information 2014/03/18
Last modified on 2015/03/18 09:19:50

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Basic information

Public title

Efficacy and safety of Exforge and Aimix in hypertensives

Acronym

Examiner study

Scientific Title

Efficacy and safety of Exforge and Aimix in hypertensives

Scientific Title:Acronym

Examiner study

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Combinations of angiotensin II type 1 receptor blockers (ARBs) and calcium channel blockers (CCBs) are recommended by various guidelines for the treatment of high blood pressure. Many kinds of single-pill fixed-dose combinations of ARBs and CCBs are available for clinical use in Japan. It is still controversial what types of single-pill fixed-dose combinations of ARBs and CCBs are useful. Therefore, we compared the efficacies and safety of two kinds of a single-pill fixed-dose combination of ARBs and CCBs (valsartan and amlodipine vs. irbesartan and amlodipine).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

1.Depressor effects at office blood pressure and the percentage of patients who reach the target office blood pressure.
2.Depressor effects at home blood pressure and the percentage of patients who reach the target home blood pressure.

Key secondary outcomes

1.Percentage of adverse effects.
2.Changes in biochemical parameters in blood and urine.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The patients with hypertension under treatment with valsartan 80 mg/day or amlodipine 5 mg/day (a single-pill fixed-dose combination) are enrolled. The patients receive a single-pill fixed-dose combination of irbesartan 100 mg/day and amlodipine 5 mg/day instead of valsartan 80 mg/day or amlodipine 5 mg/day and treated for 16 weeks. If the patient did not reach the target office BP at 8 weeks according to Japanese Society of Hypertension Guideline 2009, they received double doses of amlodipine.

Interventions/Control_2

The patients with hypertension under treatment with valsartan 80 mg/day or amlodipine 5 mg/day (a single-pill fixed-dose combination) are enrolled. The patients receive same single-pill fixed-dose combination and treated for 16 weeks. If the patient did not reach the target office BP at 8 weeks according to Japanese Society of Hypertension Guideline 2009, they received double doses of amlodipine.

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.Patients with essential hypertension who received a single-pill fixed dose combination of valsartan and amlodipine at least for 8 weeks.
2.Age is 20 years old or more.
3.Patients who gave their informed consent to participate for the present study.

Key exclusion criteria

1.Severe liver dysfunction.
2.Severe renal dysfunction.
3.Pregnancy or lactation in women.
4.Patients with a history of allergy to any component of the study medications.
5.Patients corresponding to the contraindication of study medications.
6.Ineligible patients according to the judgment by physician.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keijiro Saku

Organization

Fukuoka University School of Medicine

Division name

Department of Cardiology

Zip code


Address

7-45-1 Nanakuma, Jonan-Ku, Fukuoka.

TEL

81-92-801-1011

Email

saku-k@fukuoka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shin-ichiro Miura

Organization

Fukuoka University School of Medicine

Division name

Department of Cardiology

Zip code


Address

7-45-1 Nanakuma, Jonan-Ku, Fukuoka.

TEL

81-92-801-1011

Homepage URL


Email

miuras@cis.fukuoka-u.ac.jp


Sponsor or person

Institute

Department of Cardiology,Fukuoka University School of Medicine.

Institute

Department

Personal name



Funding Source

Organization

Department of Cardiology,Fukuoka University School of Medicine.

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

福岡大学病院(福岡県)、出水総合医療センター(鹿児島県)、井上病院(福岡県)、藤沢内科(福岡県)、松永病院(福岡県)


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 18 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

Completed

Date of protocol fixation

2013 Year 02 Month 08 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 30 Day

Last follow-up date

2014 Year 10 Month 30 Day

Date of closure to data entry

2014 Year 11 Month 30 Day

Date trial data considered complete

2014 Year 11 Month 30 Day

Date analysis concluded

2014 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 03 Month 18 Day

Last modified on

2015 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015717


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name