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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006544
Receipt No. 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 2011/10/14

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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
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
75 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
Middle name
Last name Masataka SATA
Organization The University of Tokushima Institute of Health Biosciences, Graduate School.
Division name Cardiovascular Medicine
Zip code
Address 3-18-15, Kuramoto-cho, Tokushima 770-8503
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokushima Institute of Health Biosciences, Graduate School.
Division name Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Cardiovascular Medicine. The University of Tokushima Institute of Health Biosciences, Graduate School.
Institute
Department

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
Email

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
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 Open public recruiting
Date of protocol fixation
2011 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 11 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
2011 Year 10 Month 14 Day
Last modified on
2011 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007745

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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