UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000495 |
|---|---|
| Receipt number | 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 09:30:06 |
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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
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
mmizuta@fc.miyazaki-u.ac.jp
Sponsor or person
Institute
Advanced Medicine Study Group in Kyushu Island
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000603
