UMIN-CTR Clinical Trial

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

Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Pharmacokinetics (AUC(0-inf), Cmax, t1/2) of aliskiren

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

MHLW project for structure improvement to execute early and exploratory clinical trial

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2013

Year

08

Month

29

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

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 related information

Registered date

2013

Year

08

Month

29

Day

Last modified on

2013

Year

08

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013563