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Recruitment status Suspended
Unique ID issued by UMIN UMIN000008060
Receipt No. R000006835
Scientific Title Randomized trial of Lipid lowering Therapy for Endothelial Function;Statin Monotherapy Compared with Statin/Ezetimibe or Statin/Eicosapentaenoic Acid Combination Therapy
Date of disclosure of the study information 2012/05/31
Last modified on 2018/12/04

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Basic information
Public title Randomized trial of Lipid lowering Therapy for Endothelial Function;Statin Monotherapy Compared with Statin/Ezetimibe or Statin/Eicosapentaenoic Acid Combination Therapy
Acronym Rapid Estimate
Scientific Title Randomized trial of Lipid lowering Therapy for Endothelial Function;Statin Monotherapy Compared with Statin/Ezetimibe or Statin/Eicosapentaenoic Acid Combination Therapy
Scientific Title:Acronym Rapid Estimate
Region
Japan

Condition
Condition Ischemic heart disease, Coronary atherosclerosis
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the appropriate additional therapy for endotherial function among hyperlipidemic patients uncontrolled with statin.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Improvement of endothelial function
Key secondary outcomes small dense LDL, high sensitivity CRP, oxidized LDL(MDA-LDL), pentraxin 3, high-molecular weight adiponectin, apolipoprotein A-1/B

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of atorvastatin 20mg for 6 months
Interventions/Control_2 Administration of atorvastatin 10mg plus ezetimibe 5mg for 6 months
Interventions/Control_3 Administration of atorvastatin 10mg plus ezetimibe 10mg for 6 months
Interventions/Control_4 Administration of atorvastatin 10mg plus eicosapentaenoic acid 1800mg for 6 months
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients with ischemic heart disease or coronary atherosclelosis.
2.LDL cholesterol level is from 100mg/dl to 120mg/dl with 10mg of atorvastatin.
3.No drug change during latest 3 months.
4.No history of revascularization during latest 3 months.
Key exclusion criteria 1.Patients with liver disease (ALT or AST level is over 100IU/L, total Bil level is over 2.5mg/dl).
2.Patients with renal insufficiency (serum creatinine level is over 2.0mg/dl, or creatinine clearance is under 30mL/min/1.73m2).
3.Patients with congenital heart disease.
4.Patients within 3 months from myocardial infarction and with highly advanced cardiac dysfunction.
5.Patients with endocrine disease.
6.Patients with malignancy or inflammatory disease.
7.Patinets with highly advanced respiratory disease (containing pulmonary arterial pulmonary hypertension.
8.Patients with cranial nerve disease or locomotor apparatus disease, and severely compromised daily life.
9.Patients with severe hypertension.
10.Patients administrated steroid or immune suppressor.
11.Patients with type1 DM or poorly controled type2 DM(FBS>200mg/dl, HbA1c>10.0%)
12.Patients during pregnancy or with possibility of pregnancy.
13.Patients administrated catecholamine.
14.Patients with symptomatic hypotension.
15.Patients with significant LVOT obstruction (Hypertrophic obstructive cardiomyopathy or aortic stenosis).
16.Patients recognized inadequate by primary doctor.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoritaka Otsuka
Organization Fukuoka wajiro hospital
Division name Cardiology
Zip code
Address 2-2-75, Wajirogaoka, Higashi-ku, Fukuoka city, Japan
TEL 092-608-0001
Email yotsuka@f-wajirohp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taku Koyama
Organization Fukuoka wajiro hospital
Division name Cardiology
Zip code
Address 2-2-75, Wajirogaoka, Higashi-ku, Fukuoka city, Japan
TEL 092-608-0001
Homepage URL
Email taku-koyama@umin.ac.jp

Sponsor
Institute Fukuoka wajiro hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Cerebral Cardiovascular Center Hospital
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 池友会福岡和白病院(福岡県)

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 31 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 Suspended
Date of protocol fixation
2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 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
2012 Year 05 Month 30 Day
Last modified on
2018 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006835


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