UMIN-CTR Clinical Trial

Basic information
Public title	Ambulatory blood pressure control and home blood pressure (morning and evening) lowering by N-channel blocker cilnidipine study
Acronym	Ambulatory blood pressure control and home blood pressure (morning and evening) lowering by N-channel blocker cilnidipine study (ACHIEVE ONE)
Scientific Title	Ambulatory blood pressure control and home blood pressure (morning and evening) lowering by N-channel blocker cilnidipine study
Scientific Title:Acronym	Ambulatory blood pressure control and home blood pressure (morning and evening) lowering by N-channel blocker cilnidipine study (ACHIEVE ONE)
Region	Japan

Condition
Condition	Essential Hypertension
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of L/N-type Ca2+ channel blocker, Atelec tablet, on the blood pressure levels at home (especially early morning).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in blood pressure levels at home (early morning and before bedtime) or in physician's office
Key secondary outcomes	Adverse events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Atelec-naive patients with essential hypertension
Key exclusion criteria	Pregnant or possibly pregnant patients
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuomi Kario
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code
Address	3311-1 Yakushiji, Shimonotsuke, Tochigi 329-0498, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Eiichi Ohara
Organization	Mochida Pharmaceutical Co.,Ltd.
Division name	Post-Marketing Surveillance
Zip code
Address	1-7 Yotsuya,Shinjyuku-ku,Tokyo 160-8515 Japan
TEL	03-3225-6342
Homepage URL
Email	atelec.ms.tokutei@mochida.co.jp

Sponsor
Institute	Ajinomoto Pharmaceuticals Co., LTD.
Institute
Department

Funding Source
Organization	Mochida Pharmaceutical Co.,Ltd.
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
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	2010 Year 06 Month 04 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 09 Month 01 Day
Date of IRB
Anticipated trial start date	2008 Year 10 Month 01 Day
Last follow-up date	2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This prospective observational study was designed to investigate the effect of the Atelec on blood pressure levels measured either at home (early morning and before bedtime) or in physician's office. Patients were registered by the Patient Registration Center System.

Management information
Registered date	2010 Year 06 Month 02 Day
Last modified on	2011 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004452

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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