UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006544 |
|---|---|
| Receipt number | R000007745 |
| Scientific Title | Tokushima Anti-Oxidation and RAS inhibition Clinical Trial In hypertensives, Cilnidipine versus Amlodipine |
| Date of disclosure of the study information | 2011/11/01 |
| Last modified on | 2019/12/02 13:58:01 |
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Basic information
Public title
Tokushima Anti-Oxidation and RAS inhibition Clinical Trial In hypertensives, Cilnidipine versus Amlodipine
Acronym
TACTICAL2
Scientific Title
Tokushima Anti-Oxidation and RAS inhibition Clinical Trial In hypertensives, Cilnidipine versus Amlodipine
Scientific Title:Acronym
TACTICAL2
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the anti-oxidation and RAS inhibition effect of cilnidipine (a dual N & L type calcium channel blocker) and amlodipine (a L type calcium channel blocker) in hypertensive patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Clinic blood pressure, heart rate.
2. Home blood pressure, heart rate.
3. urinary 8-OHdG
4. hs-CRP
5. urinary albumin-creatinine ratio.
6. urinary L-FABP.
7. LDL-C, TG, HDL-C, BUN, Cr, *HbA1c *fasting blood glucose (*Patients with diabetes)
8. PRA, Angiotensin, Aldsterone
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
cilnidipine (initial dose is 10mg/day 10-20mg is available depending on the blood pressure level)
Interventions/Control_2
amlodipine (initial dose is 5mg/day, but 5-10mg is available depending on the blood pressure level)
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
| 45 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Out patients
2. Patients who received an Antihypertensive treatment with RAS inhibitors.
3. Blood pressure (BP): systolic BP (SBP) 140mmHg and above or diastolic BP (DBP) 90mmHg and above.
Key exclusion criteria
1. Malignant hypertension
2. Pregnant women, or Women suspected of being pregnant.
3. Severe liver disorder.
4. Patients who are inadequate to enter this study due to the other reasons by physician's judgements.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Sata |
Organization
The University of Tokushima Institute of Health Biosciences, Graduate School.
Division name
Cardiovascular Medicine
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
088-633-7851
masataka.sata@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Soeki |
Organization
The University of Tokushima Institute of Health Biosciences, Graduate School.
Division name
Cardiovascular Medicine
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
088-633-7851
Homepage URL
soeki@tokushima-u.ac.jp
Sponsor or person
Institute
Cardiovascular Medicine. The University of Tokushima Institute of Health Biosciences, Graduate School.
Institute
Department
Personal name
Funding Source
Organization
EA pharma
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokushima Institute of Health Biosciences, Graduate School.
Address
3-18-15, Kuramoto-cho, Tokushima
Tel
088-633-7851
soeki@tokushima-u.ac.jp
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 | 11 | 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
25
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
| 2011 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 14 | Day |
Last modified on
| 2019 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007745
