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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006303
Receipt No. R000007465
Scientific Title Impact of interaction between calcium antagonists and grape fruit juice on blood pressure in clinical settings
Date of disclosure of the study information 2011/09/07
Last modified on 2016/07/28

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Basic information
Public title Impact of interaction between calcium antagonists and grape fruit juice on blood pressure in clinical settings
Acronym Impact of drug-food interactions in clinical settings
Scientific Title Impact of interaction between calcium antagonists and grape fruit juice on blood pressure in clinical settings
Scientific Title:Acronym Impact of drug-food interactions in clinical settings
Region
Japan

Condition
Condition hypertension
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence of intake of grapefruit juice on clinical and side effects of calcium antagonists in patients with hypertension.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Home blood pressure and trough drug concentration
Key secondary outcomes frequency of side effects

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 Treatment
Type of intervention
Food
Interventions/Control_1 grapefruit juice
Interventions/Control_2 water
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

Not applicable
Gender Male and Female
Key inclusion criteria Hypertensive patients treated with amlodipine or nifedipine
1) Systolic blood pressures of morning and evening are not over 200 mmHg at home in observation period.
2) Changing antihypertensive drugs was not carried out at past one month.
Key exclusion criteria 1) Patients with severe hepatic dysfunction.
2) Patients take drugs what are not allowed with grapefruit juice.
3) Patients who were judged inappropriate by doctor.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamada Hiroshi
Organization School of Pharmaceutical Sciences, University of Shizuoka
Division name Division of Drug Evaluation & Informatics
Zip code
Address 52-1,Yada,Suruga-ku,Shizuoka,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Uchida Shinya
Organization School of Pharmaceutical Sciences, University of Shizuoka
Division name Department of Pharmacy Practice and Science
Zip code
Address 52-1,Yada,Suruga-ku,Shizuoka,Japan
TEL
Homepage URL
Email

Sponsor
Institute School of Pharmaceutical Sciences, University of Shizuoka
Department of Pharmacy Practice and Science
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
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
2011 Year 09 Month 07 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
2011 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 09 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 09 Month 07 Day
Last modified on
2016 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007465

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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