UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037536 |
|---|---|
| Receipt number | 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 13:20:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
saori_matsuda@eapharma.co.jp
Sponsor or person
Institute
EA Pharma Co., Ltd.
Post-Marketing Medical Research Group, Medical Dept.
Institute
Department
Personal name
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
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
Value
https://center6.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 |
