UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002549 |
|---|---|
| Receipt number | 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 19:40:16 |
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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
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
harai@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003114
