UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013670 |
|---|---|
| Receipt number | R000015949 |
| Scientific Title | Potency of antihypertensive therapy with Azilsartan on Walking Activity among Peripheral Artery Disease Patients With hypertention and Intermittent Claudication |
| Date of disclosure of the study information | 2014/04/08 |
| Last modified on | 2015/09/29 14:33:28 |
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Basic information
Public title
Potency of antihypertensive therapy with Azilsartan on Walking Activity among Peripheral Artery Disease Patients With hypertention and Intermittent Claudication
Acronym
Potency of antihypertensive therapy with Azilsartan on Walking Activity among Peripheral Artery Disease Patients With hypertention and Intermittent Claudication
Scientific Title
Potency of antihypertensive therapy with Azilsartan on Walking Activity among Peripheral Artery Disease Patients With hypertention and Intermittent Claudication
Scientific Title:Acronym
Potency of antihypertensive therapy with Azilsartan on Walking Activity among Peripheral Artery Disease Patients With hypertention and Intermittent Claudication
Region
| Japan |
Condition
Condition
Peripheral artery disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the potency of antihypertensive therapy with AT1receptor inhibitor on Walking Activity among Peripheral Artery Disease Patients With hypertention and Intermittent Claudication
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recovery ability index(RAI) in walking exercise near infrared spectroscopy
Key secondary outcomes
1 absolute claudication distance, exercise time and Deoxygenated hemoglobin recovery time in walking exercise near infrared spectroscopy. WIQ score.
2 Anckle Brachial pressure Index,Pulse Wave Verocity,flow mediated vasodilatation,LF/HF in holter ECG, meanHR in holter ECG.
3 Blood pressure in Examination room. Mean blood pressure and Blood Pressure Type in 24hr. Ambulatory Blood Pressure Measurement.
4 Myocardial infarction, stroke and acute heart failure required hospitalization.
5 Adverse event of drug
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
medication with Azilsartan
Interventions/Control_2
medication with amlodipine
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients over 30years old
2 Mean systolic blood pressure of Twice measurement in examination is 140mmHgover or mean diastolic blood pressure is 90mmHgover
3 Patient with claudication and eGFR over 30ml/min/m2
4 Patients with agreement for this study
Key exclusion criteria
1 Patient with Critical limb ischemia
2 Life expectancy 6months
3 Medication with Cablocker or At1receptor blocker
4 inappropriate patient determined from study director
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Higashitani |
Organization
Sakakibara Heart Institute
Division name
Department of Cardiology
Zip code
Address
3-16-1 asahi-cho Futyu-shi Tokyo
TEL
042-314-3111
mhigashi@shi.heart.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Clinical Trials Support Office |
Organization
Sakakibara Heart Institute
Division name
Clinical Trials Support Office
Zip code
Address
3-16-1 asahi-cho Futyu-shi Tokyo
TEL
042-314-3111
Homepage URL
tikenjim@shi.heart.or.jp
Sponsor or person
Institute
Sakakibara heart Institute
Institute
Department
Personal name
Funding Source
Organization
Japan Research Promotion Society for Cardiovascular disease
Organization
Division
Category of Funding Organization
Non profit foundation
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
榊原記念病院 Sakakibara Heart Institute
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 08 | 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
| 2014 | Year | 04 | Month | 08 | Day |
Last modified on
| 2015 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015949
