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Recruitment status Completed
Unique ID issued by UMIN UMIN000011745
Receipt No. R000013737
Scientific Title Prospective, randomized, open-label, clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe on progression of atherosclerotic plaques and endothelial function
Date of disclosure of the study information 2013/09/14
Last modified on 2016/01/02

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Basic information
Public title Prospective, randomized, open-label, clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe on progression of atherosclerotic plaques and endothelial function
Acronym Clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe
Scientific Title Prospective, randomized, open-label, clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe on progression of atherosclerotic plaques and endothelial function
Scientific Title:Acronym Clinical trial comparing rosuvastatin monotherapy and combination therapy with ezetimibe
Region
Japan

Condition
Condition Dyslipidemia
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare rosuvastatin monotherapy and rosuvastatin-ezetimibe combination therapy on atherosclerotic plaques progression and endothelial function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Carotid atherosclerosis evaluated by ultrasound (Intima-media thickness; IMT (meanIMT/maxIMT) and plaque score)
12/24 months after randomization
(2) Area and thickness of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI)
12/24 months after randomization
(3) Flow-mediated vasodilation in forearm
6 months after randomization
Key secondary outcomes (1) Ankle/brachial index and cardio ankle vascular index
(2) Markers for diabetes (hemoglobin A1c, glycoalbumin, blood glucose)
(3) Serum lipids
(4) Markers indicating obesity (e.g. adiponectin)
(5) Markers indicating inflammation (e.g. high sensitive CRP)
(6) Markers indicating oxidative stress (8-OHdG/ MDA-LDL)
(7) Markers indicating chronic renal diseases (urine albumin/L-FABP)
(8) Blood/urine urate levels
(9) Body weight/waist circumference
(10) Blood pressures

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
Blinding Open -no one is 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 Rosuvastatin monotherapy
(titrate the dosage to achieve LDL-C target levels 30% lower than those recommended by the clinical guideline in Japan)
Interventions/Control_2 Rosuvastatin/ezetimibe combination therapy
(titrate the dosage of rosuvastatin to achieve LDL-C target levels 30% lower than those recommended by the clinical guideline in Japan)
Interventions/Control_3
Interventions/Control_4
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
80 years-old >
Gender Male and Female
Key inclusion criteria ) Dyslipidemic patients whose LDL-C levels did not reach those recommended by Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases
2) Patients who have aortic atherosclerotic plaques detected by MRI
3) Outpatients
4) Subjects who gave written informed consent
Key exclusion criteria 1) Allergy against rosuvastatin or ezetimibe
2) Poor-controlled diabetes (HbA1c>10.0 %)
3) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
4) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits.
5) End stage renal disease
6) Symptomatic (NYHA III or IV) congestive heart failure
7) Malignancies or other diseases with poor prognosis
8) Pregnant
9) Subjects whose doctor in charge do not agree to join the trial
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsunori Ikewaki
Organization National Defense Medical College
Division name Department of Internal Medicine
Zip code
Address 3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL 04-2995-1617
Email katsunorike@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ayaori
Organization National Defense Medical College
Division name Department of Internal Medicine
Zip code
Address 3-2 Namiki, Tokorozawa, JAPAN 359-8513
TEL 04-2995-1617
Homepage URL
Email ayaori@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
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 Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 14 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 08 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 14 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
2013 Year 09 Month 13 Day
Last modified on
2016 Year 01 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013737


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