UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006350 |
|---|---|
| Receipt number | R000007516 |
| Scientific Title | Preventive effect of aliskiren on migraine complicated with hypertension. |
| Date of disclosure of the study information | 2011/09/16 |
| Last modified on | 2019/01/07 10:09:09 |
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Basic information
Public title
Preventive effect of aliskiren on migraine complicated with hypertension.
Acronym
Anti-migraine effect of aliskiren
Scientific Title
Preventive effect of aliskiren on migraine complicated with hypertension.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Mamoru Shibata |
Organization
School of Medicine, Keio University
Division name
Department of Neurology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Keio University
Division name
Department of Neurology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Neurology, School of Medicine, Keio University
Institute
Department
Personal name
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)
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 | 16 | 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 | 09 | Month | 12 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007516
