UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004479 |
|---|---|
| Receipt number | R000004110 |
| Scientific Title | Effect of co-administration of Olmesartan and Azelnidipine on vascular endothelial function in patients with atherosclerosis-prone conditions. |
| Date of disclosure of the study information | 2010/10/30 |
| Last modified on | 2012/11/02 15:14:28 |
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Basic information
Public title
Effect of co-administration of Olmesartan and Azelnidipine on vascular endothelial function in patients with atherosclerosis-prone conditions.
Acronym
Effect of Olmesartan and Azelnidipine on endothelial function.
Scientific Title
Effect of co-administration of Olmesartan and Azelnidipine on vascular endothelial function in patients with atherosclerosis-prone conditions.
Scientific Title:Acronym
Effect of Olmesartan and Azelnidipine on endothelial function.
Region
| Japan |
Condition
Condition
Patients with hypertension and atherosclerosis-prone conditions.
Classification by specialty
| Medicine in general | Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine beneficial effects of co-administraetion of Olmesartan and Azelnidipine on vascular endothelial function in patients with atherosclerosis-prone conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
vascular endothelial function index
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
After the dual treatment with valsartan (80 mg/day) and amlodipine (5 mg/day) for 6 weeks, the dual treatment is switched to the treatment with olmesartan (20 mg/day) and azelnidipine (16 mg/day) for 12 weeks
Interventions/Control_2
After the dual treatment with olmesartan (20 mg/day) and azelnidipine (16 mg/day) for 6 weeks, the dual treatment is switched to the treatment with valsartan (80 mg/day) and amlodipine (5 mg/day) for 12 weeks
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) stable hypertension patients treated with valsartan (80 mg/day) and amlodipine (5 mg/day)
2) stable hypertension patients treated with olmesartan (20 mg/day) and azelnidipine (16 mg/day)
Key exclusion criteria
poor controlDM (HbA1c > 8%) or inslin usage
severe liver and/or renal dysfunction
moderate to severe heart failure (< 3 weeks)
modelate to severe heart failure (BNP > 200 pg/mL)
impossible to fix the dose oftreatments
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minako Yamaoka-Tojo |
Organization
Kitasato University Graduate Schooll of Medical Sciences
Division name
Cardioangiology
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Japan
TEL
042-778-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Cardioangology, Kitasato University Hospital
Division name
CRC center of Cardioangiology
Zip code
Address
TEL
042-778-8111
Homepage URL
Sponsor or person
Institute
Kitasato University School of Medicine, Cardioangiology
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine, Cardioangiology
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 30 | Day |
Last modified on
| 2012 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004110
