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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002549
Receipt No. R000003114
Scientific Title Comparison of diuretics and Ca antagonist for hypertension with glucose intolerance or dyslipidemia treated with candesartan
Date of disclosure of the study information 2009/11/01
Last modified on 2011/09/27

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Basic information
Public title Comparison of diuretics and Ca antagonist for hypertension with glucose intolerance or dyslipidemia treated with candesartan
Acronym Comparison of combination therapy for hypertension
Scientific Title Comparison of diuretics and Ca antagonist for hypertension with glucose intolerance or dyslipidemia treated with candesartan
Scientific Title:Acronym Comparison of combination therapy for hypertension
Region
Japan

Condition
Condition hypertension
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to compare the effect and safety of combination therapy (candesartan + thiazide or candesartan + calcium antagonist) for hypertension complicated with glucose intolerance or dyslipidemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes blood pressure after 6 months
Key secondary outcomes 1. blood sugar, lipid, and uric acid levels after 6 months
2. adverse effect

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 YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 candesartan 8mg + trichlormethiazide 0.5 mg or hydrochlorothiazide 6.25 mg
Interventions/Control_2 candesartan 8mg + amlodipine 5mg
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 Hypertensive patients with type 2 diabetes or dyslipidemia or both not reaching the goal of blood pressure according to JSH2009 under the treatment with 8mg of candesartan.
Key exclusion criteria 1. pregnant patients or patients during nursing
2. patients with severe liver dysfunction
3. patients with severe renal dysfunction (eGFR<30)
4. patients with allergy to candesartan, trichlormethiazide, hydrochlorothiazide, or amlodipine
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenori Arai
Organization Kyoto University Graduate School of Medicine
Division name Department of Human Health Sciences
Zip code
Address 53 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3861
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koh Ono
Organization Kyoto University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL 075-751-3194
Homepage URL
Email harai@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Funding for geriatric medicine research
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kyoto Medical Center
Kyoto-Katsura Hospital
Japanpost Kyoto Teishin Hospital
Mitsubishi Kyoto Hospital
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 京都大学医学部附属病院 (京都府)、京都医療センター (京都府)、京都桂病院(京都府)
京都逓信病院 (京都府)、三菱京都病院 (京都府)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 01 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
2009 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
2012 Year 09 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2013 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 25 Day
Last modified on
2011 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003114

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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