UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002862
Receipt number R000003404
Scientific Title Prospective, randomized, open-label clinical trial comparing rosuvastatin monotherapy and pravastatin-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties
Date of disclosure of the study information 2009/12/09
Last modified on 2015/12/26 14:55:20

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Basic information

Public title

Prospective, randomized, open-label clinical trial comparing rosuvastatin monotherapy and pravastatin-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties

Acronym

Prospective, randomized, open-label clinical trial comparing rosuvastatin monotherapy and pravastatin-ezetimibe combination therapy

Scientific Title

Prospective, randomized, open-label clinical trial comparing rosuvastatin monotherapy and pravastatin-ezetimibe combination therapy on progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties

Scientific Title:Acronym

Prospective, randomized, open-label clinical trial comparing rosuvastatin monotherapy and pravastatin-ezetimibe combination therapy

Region

Japan


Condition

Condition

Hypercholesterolemia

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparison of rosuvastatin monotherapy and pravastatin-ezetimibe combination therapy on atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase IV


Assessment

Primary outcomes

Area of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI), 12/24 months after randomization
Serum lipids (total/LDL/HDL-cholesterol, triglycerides), 6/12/24 months after randomization
Flow-mediated vasodilation in forearm, 6 months after randomization
Heparin-releasable EC-SOD levels, 6 months after randomization

Key secondary outcomes

Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria), 6/12/24 months after randomization


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are 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

Administration of rosuvastatin alone
(increase the dosage to meet the recommended LDL-C target levels by the clinical guideline in Japan)

Interventions/Control_2

Administration of pravastatin (increase the dosage to meet the recommended LDL-C target levels by the clinical guideline in Japan)-ezetimibe as a combination

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

1) Patients with high LDL-C levels who were recommended for administration of lipid-lowering agents in 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, pravastatin or ezetimibe
2) Administration of statin or fibrate
3) Poor-controlled hypertension (DBP>110 mmHg)
4) Poor-controlled diabetes (HbA1c>10.0 %)
5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
6) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits.
7) Chronic renal failure (serum creatinine>2.0 mg/dl)
8) Malignancies or other diseases with poor prognosis
9) Pregnant
10) Subjects whose doctor in charge do not agree to join the trial

Target sample size

60


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 I

Zip code


Address

3-2 Namiki, Tokorozawa, JAPAN 359-8513

TEL

04-2995-1597

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 I

Zip code


Address

3-2 Namiki, Tokorozawa, JAPAN 359-8513

TEL

04-2995-1597

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

Japan


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

防衛医科大学校


Other administrative information

Date of disclosure of the study information

2009 Year 12 Month 09 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

2009 Year 12 Month 08 Day

Date of IRB


Anticipated trial start date

2009 Year 12 Month 01 Day

Last follow-up date

2011 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 12 Month 08 Day

Last modified on

2015 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003404


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name