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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011598
Receipt No. R000013563
Scientific Title Independent clinical study: Researching drug-drug interaction between aliskiren and sitagliptin
Date of disclosure of the study information 2013/08/29
Last modified on 2013/08/29

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Basic information
Public title Independent clinical study: Researching drug-drug interaction between aliskiren and sitagliptin
Acronym Independent clinical study
Scientific Title Independent clinical study: Researching drug-drug interaction between aliskiren and sitagliptin
Scientific Title:Acronym Independent clinical study
Region
Japan

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

Objectives
Narrative objectives1 Investigate the drug-drug interaction between aliskiren and sitagliptin.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics (AUC(0-inf), Cmax, t1/2) of aliskiren
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 aliskiren and sitagliptin
Interventions/Control_2 aliskiren and placebo
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
35 years-old >=
Gender Male
Key inclusion criteria a) aged 20-35.
b) Male.
c) healthy based on a physical examination and medical history.
d) Can abide by ban on caffeine and alcohol during the study period.
e) Body mass index over 18.5 and under 24.9 inclusive at the time of screening.
f) The subject is able to understand and abide by the study protocol, and is willing to provide voluntary consent in writing.
g) Tested negative for examination of hepatitis (including HBs antigen and HCV antibodies)
h) Tested negative for HIV antibodies at the time of screening.
Key exclusion criteria a) Had medical history of participation in other clinical trials or the clinical study accompanied by medicine medication within three months.
b) Has hypotension (blood pressure of less than 100 mmHg during systole), hypertension (blood pressure of 140 mmHg or higher during systole) or diabetes (HbA1c NGSP 6.5% or higher).
c) Has donated or lost over 200 ml (1 unit) of blood within four weeks prior to study drug administration or 400 ml (2 units) within 3 months, or is anemic (less than Hb 12 g/dl).
d) Has a serious neurological, cerebrovascular, hepatic, renal, endocrine, cardiovascular, digestive tract (including digestive tract disorders thought to impact trial drug absorption), respiratory, or metabolic disease in their medical history or as a concomitant condition.
e) A clinically serious abnormality has been found by the principal investigator or one of the subinvestigators in the clinical test values, ECG or physical examination.
f) Had a clinically serious illness within 30 days prior to study drug administration.
g) Has used some sort of health food, or medical product within seven days prior to study drug administration or will use it during the study period.
h) Has smoked tobacco, or ingested nicotine or alcohol within 30 days prior to study drug administration and, moreover, cannot abide by the prohibition on smoking and drinking during the study period.
i) Tested positive for a specific abused substance (including alcohol) in the urine drug test at the screening.
j) Anything else that the principal investigator or one of the subinvestigators considers to be disqualifying.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Moritoyo
Organization The University of Tokyo Hospital
Division name Unit for Early and Exploratory Clinical Development
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN
TEL 03-5800-9083
Email moritoyo-tky@umin.org

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Moritoyo
Organization The University of Tokyo Hospital
Division name Unit for Early and Exploratory Clinical Development
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JAPAN
TEL 03-5800-9083
Homepage URL
Email moritoyo-tky@umin.org

Sponsor
Institute The University of Tokyo Hospital
Unit for Early and Exploratory Clinical Development
Institute
Department

Funding Source
Organization MHLW project for structure improvement to execute early and exploratory clinical trial
Organization
Division
Category of Funding Organization
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 08 Month 29 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 Completed
Date of protocol fixation
2012 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 22 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 08 Month 29 Day
Last modified on
2013 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013563

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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