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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000495
Receipt No. R000000603
Scientific Title Clinical study on anti-atherosclerotic effect of azelnidipine/amlodipine in the hypertensive patients with type 2 diabetes
Date of disclosure of the study information 2007/01/01
Last modified on 2008/12/10

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Basic information
Public title Clinical study on anti-atherosclerotic effect of azelnidipine/amlodipine in the hypertensive patients with type 2 diabetes
Acronym Anti-atherosclerotic effect of long-acting calcium channel blockers in diabetes
Scientific Title Clinical study on anti-atherosclerotic effect of azelnidipine/amlodipine in the hypertensive patients with type 2 diabetes
Scientific Title:Acronym Anti-atherosclerotic effect of long-acting calcium channel blockers in diabetes
Region
Japan

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

Objectives
Narrative objectives1 Validate predominance of long-acting calcium channel blockers(CCB) over angiotensin II receptor blockers(ARB) on anti-atherosclerotic effect in type2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes fasting plasma glucose, insulin
HbA1c
T-Chol, HDL-C, LDL-C, TG
hs-CRP, HM-adiponectine
nitrotyrosine, urinary 8-isoprostan
Key secondary outcomes home or clinic blood pressure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Randomided after 4 weeks administration of 20mg of olmesartan. 16mg of azelnizipine is administered for 8 weeks after randomization
Interventions/Control_2 Randomided after 4 weeks administration of 20mg of olmesartan. 5mg of amlozipine is administered for 8 weeks after randomization
Interventions/Control_3 20mg of olesartan is administered for 12 weeks
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients with type2 diabetes
2. Patients with hypertension
3. Outpatient
Key exclusion criteria 1. Patients using insulin
2. Patients with secondary hypertension
3. Patients on hemodialysis
4. Pregnant women or those who plan pregnancy
5. Patients with history of hypersensitivity to olmesartan, azelnizipine, amlodipine
6. Patients with severe liver injury
7. Patients with severe renal failure (serum CRE>=3.0mg/dl)
8. Other patients judged unsuitable for the study by investigator
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Masamitsu Nakazato
Organization University of Miyazaki Faculty of Medicine
Division name Division of Endocrinology and metabolism, Department of Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan
TEL 0985-85-2965
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masanari Mizuta
Organization University of Miyazaki Faculty of Medicine
Division name Division of Endocrinology and metabolism, Department of Medicine
Zip code
Address 5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan
TEL 0985-85-2965
Homepage URL
Email mmizuta@fc.miyazaki-u.ac.jp

Sponsor
Institute Advanced Medicine Study Group in Kyushu Island
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2007 Year 01 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
Date of protocol fixation
2006 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2006 Year 10 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 09 Month 29 Day
Last modified on
2008 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000603

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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