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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013460
Receipt No. 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

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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
Institute Department of Cardiology,Fukuoka University School of Medicine.
Institute
Department

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
URL(English) https://upload.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


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