UMIN-CTR Clinical Trial

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
Email	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
Email	soeki@tokushima-u.ac.jp

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

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007745