UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052604 |
|---|---|
| Receipt number | R000060026 |
| Scientific Title | The efficacy of sacubitril/valsartan in patients with poorly controlled essential hypertension. |
| Date of disclosure of the study information | 2023/10/25 |
| Last modified on | 2023/10/25 08:29:13 |
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Basic information
Public title
The efficacy of sacubitril/valsartan in patients with poorly controlled essential hypertension.
Acronym
The efficacy of sacubitril/valsartan in patients with poorly controlled essential hypertension.
Scientific Title
The efficacy of sacubitril/valsartan in patients with poorly controlled essential hypertension.
Scientific Title:Acronym
The efficacy of sacubitril/valsartan in patients with poorly controlled essential hypertension.
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of switching from azilsartan 20 mg to sacubitril valsartan 200 mg in patients with poorly controled essential hypertension despite taking azilsartan 20 mg and Ca antagonist.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Home systolic and diastolic blood pressure at baseline, 8 weeks, 24 weeks and 48 weeks after the switch.
Key secondary outcomes
The rate of achieving the target blood pressure.
The change of pulse rate.
The change of laboratory test results, including as plasma BNP level, serum creatinine level, eGFR, serum potassium level, serum uric acid level, HbA1c.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For 8 weeks prior to observation period: azilsartan 20 mg, Ca antagonist
To 48 weeks: sacubitril/valsartan 200 mg, Ca antagonist
From 8 weeks to 48 weeks: increase, decrease, or discontinue Ca antagonist, or add other antihypertensive agents (except angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers) if necessary
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
1. Patients with essential hypertension with a systolic home systolic blood pressure of 135 mmHg or higher despite treatment with azilsartan 20 mg and Ca antagonist for at least 8 weeks.
2. Any age
3. Any gender
4. Patients who have never taken sacubitril/valsartan before
5. Outpatients
6. Patients who have given written informed consent to participate in the study.
Key exclusion criteria
1. Patients with secondary hypertension
2. Patients in non-sinus rhythm or with a history of atrial fibrillation
3. Patients under treatment for heart failure, plasma BNP level >=100 pg/mL, or with a history of heart failure
4. Patients with eGFR <30mL/min/1.73m2
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tsugiyoshi |
| Middle name | |
| Last name | Yamazaki |
Organization
Tachibanadai Clinic
Division name
Department of Cardiology
Zip code
227-0046
Address
2-7-1 Tachibanadai, Aoba-ku, Yokohama, Japan
TEL
045-961-7835
md021011@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tsugiyoshi |
| Middle name | |
| Last name | Yamazaki |
Organization
Tachibanadai clinic
Division name
Department of Cardiology
Zip code
227-0046
Address
2-7-1 Tachibanadai, Aoba-ku, Yokohama, Japan
TEL
045-961-7835
Homepage URL
md021011@yahoo.co.jp
Sponsor or person
Institute
Tachibanadai clinic
Institute
Department
Personal name
Tsugiyoshi Yamazaki
Funding Source
Organization
Tachibanadai clinic
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
Isseikai Medical Corporation Ethics Committee
Address
2-2-1 Tachibanadai, Aoba-ku, Yokohama, Japan
Tel
045-962-3338
n.yamada1216@tachibanadai.or.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
たちばな台クリニック
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 25 | 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
55
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060026
