UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005837 |
|---|---|
| Receipt number | R000006809 |
| Scientific Title | Effects of calcium channel blockers on glucose tolerance and endothelial function in non-diabetic patients with essential hypertension: a comparative study between Azelnidipine and amlodipine on Glucose tolerance and Endothelial functioN - a crossover Trial (AGENT) |
| Date of disclosure of the study information | 2011/06/26 |
| Last modified on | 2011/06/22 17:46:55 |
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Basic information
Public title
Effects of calcium channel blockers on glucose tolerance and endothelial function in non-diabetic patients with essential hypertension: a comparative study between Azelnidipine and amlodipine on Glucose tolerance and Endothelial functioN - a crossover Trial (AGENT)
Acronym
AGENT
Scientific Title
Effects of calcium channel blockers on glucose tolerance and endothelial function in non-diabetic patients with essential hypertension: a comparative study between Azelnidipine and amlodipine on Glucose tolerance and Endothelial functioN - a crossover Trial (AGENT)
Scientific Title:Acronym
AGENT
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether long-acting calcium channel blockers, azelnidipine and amlodipine, could affect the glucose tolerance and endothelial function in patients with essential hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Blood pressure and heart rate
2. 75g OGTT
3. Endothelial function
Key secondary outcomes
oxidative stress marker, inflammatory marker, circulating number of progenitor cells
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
amlodipine 5mg
Interventions/Control_2
azelnidipine 16mg
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age >= 20 years old
2. Hypertensive patient with achievement of JSH 2009 goal
3. Treated with 5mg/day of amlodipine for more than 3 months
Key exclusion criteria
1. Patients with history of allergy for the study drugs
2. Patients with history of cardiovascular disorders within 3 months
3. Patients with diabetes
4. Patients with serum creatinine >= 2.0mg/dl
5. Patients with systemic diseases
6. Patients with history of gastrointestinal surgery
7. Patients who are judged inappropriate for entry into this study by the investigator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Shimada |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421 Japan
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Fukao |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421 Japan
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Juntendo University School of Medicine, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine, Department of Cardiovascular Medicine
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
| 2011 | Year | 06 | Month | 26 | 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
| 2008 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 22 | Day |
Last modified on
| 2011 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006809
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| Registered date | File name |
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| Registered date | File name |
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