UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of interaction between calcium antagonists and grape fruit juice on blood pressure in clinical settings
Title of the study (Brief title)	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	Yamada Hiroshi
Organization	School of Pharmaceutical Sciences, University of Shizuoka
Division name	Division of Drug Evaluation & Informatics
Address	52-1,Yada,Suruga-ku,Shizuoka,Japan
TEL
Email

Public contact
Name of contact person	Uchida Shinya
Organization	School of Pharmaceutical Sciences, University of Shizuoka
Division name	Department of Pharmacy Practice and Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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