UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009825
Receipt number R000009098
Scientific Title Effect of the long acting ARB in hypertensive patients with cerebro vasucular disease not controlled by conventional therapy.
Date of disclosure of the study information 2013/01/21
Last modified on 2013/01/21 11:57:54

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Basic information

Public title

Effect of the long acting ARB in hypertensive patients with cerebro vasucular disease not controlled by conventional therapy.

Acronym

Effect of the long acting ARB in hypertensive patients with cerebro vasucular disease not controlled by conventional therapy.

Scientific Title

Effect of the long acting ARB in hypertensive patients with cerebro vasucular disease not controlled by conventional therapy.

Scientific Title:Acronym

Effect of the long acting ARB in hypertensive patients with cerebro vasucular disease not controlled by conventional therapy.

Region

Japan


Condition

Condition

Cerebrovasucular Disease,
Hypertension

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of telmisartan on central blood pressure in hypertensive patients with cerebro vasucular disease not controlled by conventional therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Central blood pressure

Key secondary outcomes

Clinic BP
24hr BP on ABPM
IMT(Intra Media Dilation)
FMD(Flow Mediated Dilation)
Control rate of Clinic BP
Control rate of ABPM


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Telmisartan 80mg/day

Interventions/Control_2

Maximum dose ARB which was Prescribed originally

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Outpatients to fulfill all the following condition can participate
1)Hypertension with cerebrovasucular disease
2)Under treatment with ARB is not telmisartan more than 3 months
3)Clinic BP:SBP>=140 and/or DBP>=90
4)40 years of age and more
5)Patients with informed consent of this study

Key exclusion criteria

1)Secondary hypertension
2)Severe hypertension with SBP>=180mmHg and/or DBP>=110mmHg
3)Malignant hypertension
4)Severe heart failure (NYHA III-IV)
5)Myocardial Infarction, Coronary bypass surgery, and PTCA were performed within 6 months
6)Patients contraindicated for the use of ARBs
7)Serum creatinine >=2.1mg/dL
8)Untreated hyperuricemia or serum uric acid>8mg/dL
9)Diabetes patients under insulin treatment, or HbA1c>9.0%
10)Patients with hypoglycemia
11)Patients who are inadequate by determination of physicians in charge

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichiro Uchiyama

Organization

Tokyo Women's Medical University

Division name

Department of Neurology

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokyo Women's Medical University

Division name

Department of Neurology

Zip code


Address


TEL

03-3353-8111

Homepage URL


Email



Sponsor or person

Institute

Tokyo Women's Medical University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Women's Medical University

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


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



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 21 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

Preinitiation

Date of protocol fixation

2011 Year 03 Month 30 Day

Date of IRB


Anticipated trial start date

2013 Year 03 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

2013 Year 01 Month 21 Day

Last modified on

2013 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009098


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name