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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005330
Receipt No. R000006332
Scientific Title The verification trial of a switch-protocol from angiotensin II receptor brocker to angiotensin-converting enzyme inhibitor in a patient with hypertension
Date of disclosure of the study information 2011/04/01
Last modified on 2012/03/21

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Basic information
Public title The verification trial of a switch-protocol from angiotensin II receptor brocker to angiotensin-converting enzyme inhibitor in a patient with hypertension
Acronym The verification trial of a switch-protocol from angiotensin II receptor brocker to angiotensin-converting enzyme inhibitor in a patient with hypertension (T-SATA)
Scientific Title The verification trial of a switch-protocol from angiotensin II receptor brocker to angiotensin-converting enzyme inhibitor in a patient with hypertension
Scientific Title:Acronym The verification trial of a switch-protocol from angiotensin II receptor brocker to angiotensin-converting enzyme inhibitor in a patient with hypertension (T-SATA)
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate efficacy and safety of a switch-protocol from angiotensin II receptor brocker (ARB) to angiotensin-converting enzyme (ACE) inhibitor in an open-label and prospective clinical study used by 45 outpatients with hypertension (SBP < 160 mmHg and/or DBP < 100 mmHg), and have taken ARB for more than half year.
The subjects switch lower dose of ARB to ACE inhibitor "Lenimec" 5mg, or higher dose of ARB to Lenimec 10mg. Both groups take one tablet at a time, once a day. The transition period is 12 weeks. If the effect of the swith was insufficient, the group which takes Lenimec 5mg will be increase to 10mg, and the group with Lenimec 10mg will also be medicated with a diuretic "Fluitran". The target level of hypotensive effect will be the blood pressure measured at the beginning of the swith.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The rate of keeping the blood pressure by Lenimec compared with the first time of switching from ARB to Lenimec
1. The amount and the rate of change of the blood pressure (hospital and home)
2. The rate of the subjects who can switch from ARB to Lenimec 5mg only
3. The rate of the subjects who increase Lenimec 10mg from 5mg and have completed a switch.
4. The rate of the subjects who first start switching Lenimec 10mg and have completed a switch
Key secondary outcomes The rate of keeping the blood pressure by Lenimec + Fluitran compared with the first blood pressure of switching from ARB to Lenimec

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 1) The subjects switch lower dose of ARB to ACE inhibitor "Lenimec" 5mg, or higher dose of ARB to Lenimec 10mg. Both groups take one tablet at a time, once a day.
2) The target level of hypotensive effect will be the blood pressure (hospital) measured at the beginning of the swith.
The transition period is 12 weeks.
3) If the effect of the swith was insufficient, the group which takes Lenimec 5mg will be increase to 10mg, and the group with Lenimec 10mg will also be medicated with a diuretic "Fluitran".
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) The patients who have only taken ARB over half year
2) The patients who have taken ARB by usual dosage
3) The patients with essential hypertension whose blood pressure is under control within SBP < 160mmHg and/or DBP < 100mmHg
4) The patients who are able to use a sphygmomanometer with data transfer function
5) The patients who are able to use PHS communication network at the location of home blood pressure measurement
6) The patients who do not take the supplements or the health foods which an effect on blood pressure improving metabolic syndrome suggests, or are based on a mineral such as calcium during study period.
7) Outpatients.
8) The subjects who submit the informed consent of this study
Key exclusion criteria 1) The patients who will take antihypertensive drugs except ARB or ACE inhibitor
2) The patients who have already changed to ARB by the adverse effects (dry cough) of ACE inhibitor
3) The patients who are class II and III hypertension
4) The secondary hypertension patients.
5) The patients with stroke, myocardial infarction and serious vascular disease to require hospitalization within six months
6) The patients with hepatic dysfunction (the levels of AST (GOT) and ALT (GPT) exceed 3 times of the standard value (facility criteria).)
7) The patients with renal dysfunction
8) The patients with heart failure over NYHA III
9) The patients with malignancy and poor-prognosis critical disorders.
10) The patients with history of angioedema.
11) The patients who have been treated with the apheresis system using a dextran sulfate immobilized cellulose, a tryptophan immobilized polyvinyl alcohol or a polyethylene terephthalate
12) The patients on hemodialysis with membrane using acrylonitrile methallyl sulphonate.
13) The patients with anuria.
14) The patients who decrease in sodium and potassium in the body fluid.
15) Female patients who are pregnant or hope for pregnancy during the research.
16) The patients with history of hypersensitivity to enalapril, thiazide drugs, or analogous compound.
17) The patients who judged the principal investigator (or the subinvestigators) to be inappropriate from a medical base
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Etsu Katsuro
Organization Kanetsu hospital
Division name Internal medicine
Zip code
Address 145-1 Suneori, Tsurugashima, Saitama, 350-2213
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motoki Arakawa
Organization School of Pharmacy, Nihon University
Division name Laboratory of Pharmaceutical Regulatory Science
Zip code
Address 7-7-1 Narashinodai, Funabashi, Chiba, 274-8555
TEL
Homepage URL
Email

Sponsor
Institute Kanetsu hospital
Institute
Department

Funding Source
Organization "High-Tech Research Center" Project
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Laboratory of Pharmaceutical Regulatory Science, School of Pharmacy, Nihon University
Cyber Cross Japan, Ltd.
SRL, Ltd.
School of Medicine, Showa University
Graduate school of Medicine, Tokyo University
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 社会医療法人社団 新都市医療研究会[関越]会 関越病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 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
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 Terminated
Date of protocol fixation
2010 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 28 Day
Last modified on
2012 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006332

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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