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Recruitment status Terminated
Unique ID issued by UMIN UMIN000003978
Receipt No. R000004729
Scientific Title Nagasaki Investigation of Candesartan Effects -the Comparison Between an Increased Candesartan and the additional Diuretics-
Date of disclosure of the study information 2010/08/07
Last modified on 2013/02/03

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Basic information
Public title Nagasaki Investigation of Candesartan Effects
-the Comparison Between an Increased Candesartan and the additional Diuretics-
Acronym NICE-C
Scientific Title Nagasaki Investigation of Candesartan Effects
-the Comparison Between an Increased Candesartan and the additional Diuretics-
Scientific Title:Acronym NICE-C
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to examine the differences of the organ protective effects by between increased dose of candesartan to 12mg/day and the additional administration of hydrochlorothiazide, 6.25mg/day, in hypertensive patients taking candesartan of 8mg/day.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in blood pressure values in outpatient clinic.
Changes in the levels of urine microalbumin, NT-proBNP, high-sensitive CRP, and HbA1c.
Key secondary outcomes Flow mediated dilation
Augmentation index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
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 Administration of dose-up of candesartan (from 8mg to 12mg/day) for 6 months
Interventions/Control_2 Additional adminstration of 6.25mg/day of hydrochlorothiazide for 6 months
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with essential hypertension who has the insufficient values of blood pressure under taking antihypertensive agents except diuretics and additional administration of 8mg/day of candesartan for at least 3 months are enrolled.
Incrusion criteria included the following:
(1)Patients in outpatient clinic
(2)Male or female of more than 40 years
(3)Patients with more than 135 mmHg in systolic blood pressure or 85 mmHg in diastolic blood pressure on 2 times of most recent measurements of blood pressure at sitting position
(4)Patients who agreed to attend to this study
Key exclusion criteria Exclusion criteria comprised any of the following:
(1)Patients under treatments with antihypertensive agents except diuretics who will not continue to take 8mg/day of candesartan for at least 3 months.
(2)Administration of diuretics or of agents influencing rennin-angiotensin-aldosterone system except for candesartan.
(3)Concomitant medications which are expected to be frequently changed.
(4)Under treatment of insulin for diabetes.
(5)Severe renal dysfunction (eGFR<30 mL/min/1.73m2)
(6)Heart failure (NYHA classification III or IV)
(7)Malignant hypertension and secondary hypertension.
(8)Myocardial infarction, stroke, and revascularization therapies of coronary arteries and/or peripheral arteries within 6 months prior to the registration of this study.
(9)Pregnant female
(10)Allergic disorder which is problem in the clinical setting. Hypersensitivity or contraindication to candesartan or hydrochlorothiazide.
(11)Patients who are judged by doctors as inappropriate patients for the entries of this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Maemura
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Cardiovascular Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki, Japan
TEL 095-819-7288
Email

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Ikeda
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Cardiovascular Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki, Japan
TEL 095-819-7288
Homepage URL
Email sikeda@nagasaki-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization None
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 長崎大学病院(長崎県)、えぐち内科ステーションクリニック(長崎県)、嬉野医療センター(佐賀県)、川棚医療センター(長崎県)、久保内科病院(長崎県)、佐世保市立総合病院(長崎県)、佐世保中央病院(長崎県)、千住病院(長崎県)、北松中央病院(長崎県)、長崎労災病院(長崎県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 07 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 Terminated
Date of protocol fixation
2010 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 01 Day
Date trial data considered complete
2012 Year 06 Month 01 Day
Date analysis concluded
2012 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 02 Day
Last modified on
2013 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004729

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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