UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003882 |
|---|---|
| Receipt number | R000004673 |
| Scientific Title | Comparison of the Pleiotropic Effects between Pravastatin and Ezetimibe |
| Date of disclosure of the study information | 2010/07/07 |
| Last modified on | 2014/05/13 10:57:34 |
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Basic information
Public title
Comparison of the Pleiotropic Effects between Pravastatin and Ezetimibe
Acronym
Comparison of the Pleiotropic Effects between Pravastatin and Ezetimibe (COMPLETE study)
Scientific Title
Comparison of the Pleiotropic Effects between Pravastatin and Ezetimibe
Scientific Title:Acronym
Comparison of the Pleiotropic Effects between Pravastatin and Ezetimibe (COMPLETE study)
Region
| Japan |
Condition
Condition
High LDL-cholesterol level
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the effectiveness and safety between Pravastatin and Ezetimibe in patients with high LDL-cholesterol level, concerning various lipid and lipoprotein parameters, oxidized cholesterol and oxidized stress markers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Changing ratio of Cholesterol Absorption Markers
Key secondary outcomes
1) LDL-C, HDL-C and TG levels
2) Various lipid parameters including lipoprotein subclass and oxidized stress markers
3) Oxidized cholesterol level
4) Relationship between cholesterol absorption / synthesis markers and various lipid parameters including lipoprotein subclass and oxidized stress markers before the intervention of drugs
5) Relationship between changing value / ratio of LDL-C and cholesterol absorption / synthesis markers after the intervention of drugs
6) Relationship between changing value / ratio of oxidized cholesterol and cholesterol absorption / synthesis markers after the intervention of drugs
7) Diabetic parameters
8) Inflammatory parameters
9) Safety of drug usage
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ezetimibe Group
Interventions/Control_2
Pravastatin Group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Inclusion Criteria
Outpatient whose LDL-C level was <180 mg/dl and who has not achieved lipid management goals based on risk assessment by Japan Atherosclerosis Society(JAS) Guidelines for Diagnosis and Prevention of Atherosclerotic Cardiovascular Diseases, 2007 Edition.
2) Eligibility Criteria
(1)Patient who can be administrated either Ezetimibe or Pravastatin for the newly started lipid-lowering therapy
(2)Patient who gave informed consent for the participation of this study
Key exclusion criteria
(1) Patient whose TG level was >150mg/dl at the entry period
(2) Patient who suffered from moderate or severe hepatic dysfunction
(3) Patients with acute coronary syndrome including unstable angina and acute myocardial infarction, old myocardial infarction and heart failure (Patients who are treated for the secondary prevention for heart disease
(4) Patient with newly onset cerebrovascular disease (within 12 weeks after the onset)
(5) Patient with uncontrolled diabetes mellitus (HbA1c>8.5%)
(6) Patient with past history of drug allergy including shock, anaphylactic reaction or angioedema
(7) Patient who took immunosuppressive drugs
(8) Patient with familial hypercholesterolemia
(9) Patient with hyperlipidemia caused by the following diseases; hypothyroidism, obstructive cholangitis, pancreatitis, Cushing disease, erythematosus, malignant lymphoma, Myeloma, Uncontrolled diabetes Mellitus
(10) Alcoholics
(11) Patient with hyperlipidemia caused by the steroid hormone or other related drugs
(12) Patient who was pregnant or suckling, has the possibility of pregnancy or the wish of pregnancy by herself or her partner.
(13) Patient who has the hypersensitivity of these drugs including their additive agent
(14) Patient whom the doctor judged inappropriate
(1) Patient who took specific health food containing plant sterols
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shizuya Yamashita |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Yamadaoka 2-2, Suita, Osaka, 5650871, Japan
TEL
06-6879-3633
shizu@cardiology.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisaku Masuda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Yamadaoka 2-2, Suita, Osaka, 5650871, Japan
TEL
06-6879-3633
Homepage URL
masuda@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Rinku General Medical Center(Osaka)
Osaka Central Hospital (Osaka)
Toyonaka Municipal Hospital(Osaka)
Suita Municipal Hospital(Osaka)
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
大阪大学医学部付属病院（大阪府）
りんくう総合医療センター 市立泉佐野病院（大阪府）
大阪中央病院（大阪府）
市立豊中病院（大阪府）
市立吹田市民病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 07 | 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
| 2009 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 07 | Day |
Last modified on
| 2014 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004673
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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