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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003756
Receipt No. R000004551
Scientific Title Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Prospective Open Label Trial-
Date of disclosure of the study information 2010/06/15
Last modified on 2010/11/05

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Basic information
Public title Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Prospective Open Label Trial-
Acronym Aortic Plaques Prevention Trial by Etidronate and Atorvastatin
Scientific Title Effect of the Combination Therapy of Etidronate and Atorvastatin on Atherosclerotic Abdominal Aortic Plaques Detected by Magnetic Resonance Imaging - Prospective Open Label Trial-
Scientific Title:Acronym Aortic Plaques Prevention Trial by Etidronate and Atorvastatin
Region
Japan

Condition
Condition Hyperlipidemia, Diabetes, Hypertension, Osteoporosis
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Regression of thoracic aortic plaques by statins was demonstrated. However, because of differences between the property of abdominal aortic plaque and thoracic aortic plaque, the regression effects on abdominal aortic plaque have not been observed. We aimed to determine whether the combination treatment of statin and bisphosphonate was more effective than statin or bisphosphonate treatment in regression of aortic plaques.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The changing rate (%) of hyperplasia in Maximal Wall Thickness after one year
...ATR + ETD group vs. ATR group
Key secondary outcomes The changing rate (%) of Total Vascular Area and Lumen Area after one year
The changing rate (%) of LDLchol value after one year
...ATR + ETD group vs. ATR group,

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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 Atorvastatin + Etidronate (ATR+ETD) group
Janu. 2006-Apr.2008
Interventions/Control_2 Atorvastatin (ATR) group
Jan. 2006-Apr.2008
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Pulse Wave Velocity > 1800
carotid artery echo: plaque score > 3
200 > LDL cholesterol > 160mg/dl
Not take an improving drug of lipid metabolism for 3 months. Not take an improving drug of osteoporosis for 3 months
Key exclusion criteria The patients who have psychic disturbance, Collagen disease, liver renal dysfunction, heart disorder, cerebrovascular disorder, and or serious complications. The patients who were decided that participation is inappropriate for them by chief physician.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Kawahara
Organization Niigata Rosai Hospital
Division name Endocrinology and Metabolism
Zip code
Address 1-7-12, Touncho, Joetsu-shi, Niigata, Japan
TEL 025-543-3123
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Kawahara
Organization Niigata Rosai Hospital
Division name Endocrinology and Metabolism
Zip code
Address 1-7-12, Touncho, Joetsu-shi, Niigata, Japan
TEL 025-543-3123
Homepage URL http://www.niigatah.rofuku.go.jp/
Email k-tetsuy@niirou.jp

Sponsor
Institute Niigata Rosai Hospital
Institute
Department

Funding Source
Organization Niigata Rosai Hospital
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Institute of Public Health
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 新潟労災病院(新潟県)

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 15 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
2005 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2008 Year 04 Month 01 Day
Date of closure to data entry
2008 Year 06 Month 01 Day
Date trial data considered complete
2008 Year 07 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 15 Day
Last modified on
2010 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004551

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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