UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preventive effect of aliskiren on migraine complicated with hypertension.
Title of the study (Brief title)	Anti-migraine effect of aliskiren
Region	Japan

Condition
Condition	hypertension migraine
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Renin-angiotensin modulators are known to possess an anti-migraine effect. The objective of the present study is to determine whether treatment with the direct renin inhibitor aliskiren is effective as a migraine-prophylactic drug.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The number of days with migraine per month
Key secondary outcomes	The number of headache attacks per month

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of alisliren
Interventions/Control_2	Administration of candesartan
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	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Individuals with informed consent 2. Aged more than 18 years and below 65 years. 3. Hypertensive subjects who satisfy the diagnostic criteria of migraine according to ICHD-II and who have been keeping a headache diary more than one month before entry. 4. Individuals who have had migraine attacks (2-6 times) in the last three months. 5. Those who have moderate or severe hypertension.
Key exclusion criteria	1. Individuals taking an ACE inhibitor or ARB. 2. Those who fail to submit informed consent. 3. Those who may be allergic to aliskiren or candesartan. 4. SBP>180 mmHg or DBP>110 mmHg. 5. Those who are pregnant or hope to get pregnant. 6. Menstruation-related migraine patients. 7. Those who are taking cyclosporine. 8. Those who have severe hepatic dysfunction and/or renal dysfunction. 9. Those who are judged not to be eligible for entry to this study by their attending physician.
Target sample size	20

Research contact person
Name of lead principal investigator	Mamoru Shibata
Organization	School of Medicine, Keio University
Division name	Department of Neurology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Email

Public contact
Name of contact person
Organization	School of Medicine, Keio University
Division name	Department of Neurology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Department of Neurology, School of Medicine, Keio University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 12 Day
Anticipated trial start date	2011 Year 09 Month 13 Day
Last follow-up date	2013 Year 09 Month 30 Day
Date of closure to data entry	2013 Year 09 Month 30 Day
Date trial data considered complete	2013 Year 09 Month 30 Day
Date analysis concluded	2013 Year 09 Month 30 Day

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

Management information
Registered date	2011 Year 09 Month 15 Day
Last modified on	2019 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007516