Unique ID issued by UMIN | UMIN000005661 |
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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 |
The trial of the influence of circadian rhythms of melatonin by losartan
The trial of the influence of circadian rhythms of melatonin by losartan (T-CML)
The trial of the influence of circadian rhythms of melatonin by losartan
The trial of the influence of circadian rhythms of melatonin by losartan (T-CML)
Japan |
Hypertension
Cardiology |
Others
NO
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.
Safety
Exploratory
Pragmatic
Phase I
The amount and the rate of change of the AUC and the peak value of the melatonin plasma level
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)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Medicine |
The subjects take Losartan 50mg at a time, once a day, after the breakfast, for seven days.
20 | years-old | <= |
45 | years-old | > |
Male
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.
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
10
1st name | |
Middle name | |
Last name | Katsuo Kanmatsuse |
Tokyo heart center, Osaki hospital
Cardiovascular internal medicine
5-4-12 Kitashinagawa, Shinagawa, Tokyo 141-0001
1st name | |
Middle name | |
Last name | Motoki Arakawa |
School of Pharmacy, Nihon University
Laboratory of Pharmaceutical Regulatory Science
7-7-1 Narashinodai, Funabashi, Chiba 274-8555
047-465-6292
arakawa.motoki@nihon-u.ac.jp
Tokyo Heart Center, Dept of Clinical Pharmacology Laboratory
"High-Tech Research Center" Project
Japan
Laboratory of Pharmaceutical Regulatory Science, School of Pharmacy, Nihon University
SRL, Ltd.
School of Medicine, Showa University
Graduate school of Medicine, Tokyo University
None
NO
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)
2011 | Year | 05 | Month | 27 | Day |
Unpublished
Melatonin content was not significantly decreased by Losartan taking 1 week.
Completed
2011 | Year | 05 | Month | 20 | Day |
2011 | Year | 05 | Month | 01 | Day |
2011 | Year | 05 | Month | 27 | Day |
2011 | Year | 09 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006690
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