UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025555 |
|---|---|
| Receipt number | R000029244 |
| Scientific Title | HMG-CoA Reductase Inhibitor for postmenopausal patients used as Arterial stiffness (ASI) index ; A Phase II randomized controlled study |
| Date of disclosure of the study information | 2017/01/06 |
| Last modified on | 2017/01/06 09:49:32 |
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Basic information
Public title
HMG-CoA Reductase Inhibitor for postmenopausal patients used as Arterial stiffness (ASI) index ; A Phase II randomized controlled study
Acronym
HMG-CoA Reductase Inhibitor for postmenopausal patients used as ASI index
Scientific Title
HMG-CoA Reductase Inhibitor for postmenopausal patients used as Arterial stiffness (ASI) index ; A Phase II randomized controlled study
Scientific Title:Acronym
HMG-CoA Reductase Inhibitor for postmenopausal patients used as ASI index
Region
| Japan |
Condition
Condition
Postmenopausal women (70> age >40years) with hypecholesterolemia (LDL> 140mg/dl)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
HMG-CoA Reductase Inhibitor for postmenopausal patients with hypecholesterolemia with randomized control phase II study examine whether exercise therapy and dietary therapy and HMG-CoA Reductase Inhibitor are superior to therapy and dietary therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
the rate of change of ASI 1 year later after treatment
Key secondary outcomes
the rate of change of TCHO, LDL and HDL value 1 year later after treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
kinesitherapy and deiotherapy are based on third Report of the National Cholesterol Education Program (NCEP) for 1 year.
Interventions/Control_2
Pravastatin (10mg/day) is administered for 1 year.
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
Postmenopausal women with hypercholesterolemia (LDL>=140mg/dl)
Key exclusion criteria
1.familial hypercholesterolemia
2.allergy to Pravastatin
3.pregnant woman
4.hypertension
5.angina pectoris or myocardial infarction
6.stroke
7.Atrial fibrillation
8.Rheumatism
9.hepatitis or Cirrhosis of the liver
10.cancer patient
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuji Kawaguchi |
Organization
Nara Medical University
Division name
Obstetrics and Gynecology
Zip code
Address
840 shijocho, Kashihara, Nara, Japan
TEL
0744-22-3051
kawaryu@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuji Kawaguchi |
Organization
Nara Medical University
Division name
Obstetrics and Gynecology
Zip code
Address
840 shijocho, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
kawaryu@naramed-u.ac.jp
Sponsor or person
Institute
Obstetrics and Gynecology, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
奈良県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 06 | 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
| 2013 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 06 | Day |
Last modified on
| 2017 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029244
