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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037536
Receipt No. R000042750
Scientific Title A post-marketing survey evaluating the safety and efficacy of a fixed-dose single-pill combination of cilnidipine and valsartan in patients with hypertension
Date of disclosure of the study information 2019/07/30
Last modified on 2019/07/29

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Basic information
Public title A post-marketing survey evaluating the safety and efficacy of a fixed-dose single-pill combination of cilnidipine and valsartan in patients with hypertension
Acronym HOPE-Combi survey
Scientific Title A post-marketing survey evaluating the safety and efficacy of a fixed-dose single-pill combination of cilnidipine and valsartan in patients with hypertension
Scientific Title:Acronym HOPE-Combi survey
Region
Japan

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

Objectives
Narrative objectives1 To investigate the safety and efficacy of long term use of ATEDIO Combination Tablet (cilnidipine 10mg and valsartan 80mg) in the real world
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Incidence of adverse drug reactions

Efficacy
1) Changes in office or home blood pressure levels and pulse rate
2) Changes in office blood pressure from baseline to study end (baseline, 3, 6, 9 and 12 months)
3) Changes in office pulse rate from baseline to study end (baseline, 3, 6, 9 and 12 months)
4) Changes in office pulse rate in relation to baseline office pulse rate: all, 75 or more but less than 85 beats/min, 85 beats/min or more
5) Changes in the percentage of patients categorized by office blood pressure and home blood pressure ate at baseline and after 12 months (normotension: less than 135 mmHg of home blood pressure and less than 140 mmHg of office blood pressure, hypertension: 135 mmHg or more of home blood pressure and 140 mmHg or more of office blood pressure, masked hypertension: 135 mmHg or more of home blood pressure and less than140 mmHg of office blood pressure, white cote hypertension: less than 135 mmHg of home blood pressure and 140 mmHg or more of office blood pressure)
6) The proportions of patients achieved the OBP targets BP were investigated according to the target BP level in JSH 2019 or JSH 2014
Key secondary outcomes Sub-analysis 1: Morning home blood pressure and pulse pressure
1) Changes in morning home blood pressure, pulse pressure and pulse rate from baseline to study end (baseline, 3, 6, 9 and 12 months)
2) Changes in morning home systolic blood pressure in 2 categories of baseline morning pulse rate: less than 70 beats/min, 70 beats /min or more (baseline, 3, 6, 9 and 12 months)
3) Scatter plot of the linear relationship between the baseline morning home systolic blood pressure and the change in morning home systolic blood pressure: baseline and after 3 months, baseline and after 12 months
4) Time course of morning home pulse pressure (quantile of pulse pressure) at morning home pulse rate: less than 70 bpm, 70 bpm or more (baseline, 3, 6, 9 and 12 months)

Sub-analysis 2: Day-by-day variability of morning home systolic blood pressure
1) Time course of morning systolic blood pressure and parameters of variability of morning systolic blood pressure (baseline, 3 and 12 months)
2) Time course of morning systolic blood pressure and parameters of variability of morning systolic blood pressure by age: less than 70 years, 70 years or more (baseline, 3 and 12 months)

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 Hypertensive patients who newly started administering ATEDIO Combination Tablet
Key exclusion criteria 1) Violation of registration criteria
2) Lost to follow up after initial visit
3) Not administered
Target sample size 2200

Research contact person
Name of lead principal investigator
1st name Kazuomi
Middle name
Last name Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular, Medicine, Department of Medicine
Zip code 329-0498
Address 3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan 329-0498, Japan
TEL 0285-58-7538
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name Saori
Middle name
Last name Matsuda
Organization EA Pharma Co., Ltd.
Division name Post-Marketing Medical Research Group, Medical Dept.
Zip code 104-0042
Address 2-1-1, Irifune, Chuo-ku, Tokyo 104-0042, Japan
TEL 03-6280-9512
Homepage URL
Email saori_matsuda@eapharma.co.jp

Sponsor
Institute EA Pharma Co., Ltd.
Post-Marketing Medical Research Group, Medical Dept.
Institute
Department

Funding Source
Organization EA Pharma Co., Ltd.
Post-Marketing Medical Research Group, Medical Dept.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Mochida Pharmaceutical Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization EA Pharma Co., Ltd.
Address 2-1-1, Irifune, Chuo-ku, Tokyo 104-0042, Japan
Tel 03-6280-9512
Email saori_matsuda@eapharma.co.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
2019 Year 07 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 2622
Results
Data were collected for 2095 patients. A total of 2045 patients met the criteria of this surveillance protocol. Among these patients, 53.6% were male, 46.4% were female, and the average age was 67.5 years.
Seventy two cases (3.52%) of adverse drug reactions were observed. Systolic blood pressure, diastolic blood pressure, and pulse rate, measured either at office or at home, decreased significantly after 3 months, and this effect was maintained for 12 months.
Results date posted
2019 Year 07 Month 26 Day
Results Delayed
Delay expected
Results Delay Reason Survey method and results are unpublished
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
2014 Year 02 Month 26 Day
Date of IRB
2013 Year 02 Month 26 Day
Anticipated trial start date
2014 Year 10 Month 15 Day
Last follow-up date
2017 Year 07 Month 31 Day
Date of closure to data entry
2017 Year 07 Month 31 Day
Date trial data considered complete
2017 Year 08 Month 01 Day
Date analysis concluded
2018 Year 07 Month 24 Day

Other
Other related information This study is conducted prospectively and observationally. Patients are registered by the Patient Registration Center System.

Management information
Registered date
2019 Year 07 Month 30 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042750

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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