UMIN-CTR Clinical Trial

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

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kanetsu hospital

Institute

Department

Personal name

Organization

"High-Tech Research Center" Project

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2011

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

03

Month

28

Day

Last modified on

2012

Year

03

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006332