UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011745
Receipt number 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 16:53:00

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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


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



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 or person

Institute

National Defense Medical College

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013737


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name