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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003882
Receipt No. 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

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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
Email 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
Email masuda@cardiology.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine, Department of Cardiovascular Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004673

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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