UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000236 |
|---|---|
| Receipt number | R000000297 |
| Scientific Title | Clinical study to investigate the effects of olmesartan and azelnidipine in patients with hypertesnion and arteriosclerosis obliterans |
| Date of disclosure of the study information | 2008/01/01 |
| Last modified on | 2005/09/14 16:14:58 |
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Basic information
Public title
Clinical study to investigate the effects of olmesartan and azelnidipine in patients with hypertesnion and arteriosclerosis obliterans
Acronym
Clinical study to investigate the effects of olmesartan and azelnidipine in patients with hypertesnion and arteriosclerosis obliterans
Scientific Title
Clinical study to investigate the effects of olmesartan and azelnidipine in patients with hypertesnion and arteriosclerosis obliterans
Scientific Title:Acronym
Clinical study to investigate the effects of olmesartan and azelnidipine in patients with hypertesnion and arteriosclerosis obliterans
Region
| Japan |
Condition
Condition
Patients with essential hypertension and arteriosclerosis obliterans(ASO)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the anti-arteriosclerotic effects of Olmesartan in patients with ASO and hypertension, compared with azelnidipine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
Changes from baseline in blood pressure
(Casual blood pressure and ABPM)
Changes from baseline in intima media thickness in femoral arteries and carotid arteries
Safety
Adverse event and laboratory tests
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Olmesartan medoxomil will be administered during the study for one year.
Interventions/Control_2
Azelnidipine will be administered during the study for one year.
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
1)Patients with ASO
2)ABPI(Ankle brachial pressure index) <0.9
3)Average sitting systoric blood pressure > 140mmHg and sitting diastoric blood pressure > 90mmHg
Key exclusion criteria
1) Fontane classification III or IV
2) Immediate requirement for surgical operation
3) Myocardial infarction, unstable angina pectoris, stroke or transient ischemic atttack within 6 months before giving informed consent
4) Deep-vein thrombosis within 3 months before giving informed consent
5) Malignancy that requires treatment
6) Liver dysfunction (AST and ALT>100IU/L)
7) Renal dysfunction (creatinine>3.0mg/dL)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Kumakura |
Organization
Cardiovascular Hospital of Central Japan
Division name
Department of Internal Medicine
Zip code
Address
740 Shimohakoda, Hokkitsu-mura, Seta-gun, Gunma, 377-0061, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisao Kumakura |
Organization
Cardiovascular Hospital of Central Japan
Division name
Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
kumakura@sannet.ne.jp
Sponsor or person
Institute
Cardiovascular Hospital of Central Japan
Institute
Department
Personal name
Funding Source
Organization
Cardiovascular Hospital of Central Japan
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
| 2008 | 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
| 2005 | Year | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 12 | 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
| 2005 | Year | 09 | Month | 14 | Day |
Last modified on
| 2005 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000297
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
