UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005661
Receipt number R000006690
Scientific Title The trial of the influence of circadian rhythms of melatonin by losartan
Date of disclosure of the study information 2011/05/27
Last modified on 2011/09/24 13:26:10

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Basic information

Public title

The trial of the influence of circadian rhythms of melatonin by losartan

Acronym

The trial of the influence of circadian rhythms of melatonin by losartan (T-CML)

Scientific Title

The trial of the influence of circadian rhythms of melatonin by losartan

Scientific Title:Acronym

The trial of the influence of circadian rhythms of melatonin by losartan (T-CML)

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We evaluate the influence on a biological rhythm of the melatonin in an open-label and prospective clinical study used by 10 healthy adult males who take Losartan 50mg at a time, once a day, after the breakfast, for seven days.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

The amount and the rate of change of the AUC and the peak value of the melatonin plasma level

Key secondary outcomes

The correlation between the AUC and the peak value of the melatonin plasma level and the following item
1) The amount of change of blood pressure (hospital)
2) The amount of change of blood pressure (home)


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

Prevention

Type of intervention

Medicine

Interventions/Control_1

The subjects take Losartan 50mg at a time, once a day, after the breakfast, for seven days.

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

45 years-old >

Gender

Male

Key inclusion criteria

The subjects are a healthy adult man.
1) The subjects are health admitted by the principal investigator (or the subinvestigators).
2) The subjects don't take antihypertensive drugs now, and there is no history of taking ARB, ACE inhibitor and a direct renin inhibitor
3) The subjects can take breakfast, lunch, and dinner during this study.
4) The subjects can avoid alcoholic beverages.
5) The subjects can use the digital automatic sphygmomanometer (made in Omron HEM-7080IC) used by home blood pressure measurement.
6) The subjects don't take the supplements or the health foods which an effect on blood pressure suggests, or are based on a mineral such as calcium during study period.
7) The subjects submit the informed consent of this study.

Key exclusion criteria

1) The subjects with class I to class III hypertension (SBP >= 140mmHg and/or DBP >= 90mmHg)
2) The subjects prescribe beta-blockade medicine, alpha-blockade medicine, diuretic agent and oral steroid medicine, and also have to continue during this study.
3) The patients with secondary hypertension
4) The subjects with orthostatic hypotension, syncope and adynamia by orthostatic hypotension
5) The subjects with stroke, myocardial infarction and serious vascular disease to require hospitalization within six months
6) The subjects mainly do the work at night.
7) The subjects have taken a trip to foreign countries with the time difference within one week before the study starting.
8) The person with the life pattern that reverses day and night within one week before the study starting.
9) The patients who judged the principal investigator (or the subinvestigators) to be inappropriate from a medical base

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuo Kanmatsuse

Organization

Tokyo heart center, Osaki hospital

Division name

Cardiovascular internal medicine

Zip code


Address

5-4-12 Kitashinagawa, Shinagawa, Tokyo 141-0001

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

047-465-6292

Homepage URL


Email

arakawa.motoki@nihon-u.ac.jp


Sponsor or person

Institute

Tokyo Heart Center, Dept of Clinical Pharmacology Laboratory

Institute

Department

Personal name



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
SRL, Ltd.
School of Medicine, Showa University
Graduate school of Medicine, Tokyo University

Name of secondary funder(s)

None


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

医療法人社団 冠心会 大崎病院 東京ハートセンター 臨床薬理研究所 (東京都)


Other administrative information

Date of disclosure of the study information

2011 Year 05 Month 27 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

Melatonin content was not significantly decreased by Losartan taking 1 week.

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

Completed

Date of protocol fixation

2011 Year 05 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 05 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 05 Month 27 Day

Last modified on

2011 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006690


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name