UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006303 |
|---|---|
| Receipt number | 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 20:09:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
School of Pharmaceutical Sciences, University of Shizuoka
Department of Pharmacy Practice and Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007465
