UMIN-CTR Clinical Trial

Basic information
Public title	Effects of pravastatin and ezetimibe on inflammatory markers and endothelial function in dyslipidemic patients
Acronym	Effects of pravastatin and ezetimibe on inflammatory markers and endothelial function
Scientific Title	Effects of pravastatin and ezetimibe on inflammatory markers and endothelial function in dyslipidemic patients
Scientific Title:Acronym	Effects of pravastatin and ezetimibe on inflammatory markers and endothelial function
Region	Japan

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

Objectives
Narrative objectives1	This study is performed to investigate the effects of pravastatin and ezetimibe on inflammatory markers and endothelial function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) inflammatory molecules (CRP, TNFa, MCP-1, S100 proteins) in blood and white blood cells (2) Flow-mediated vasodilation in brachial artery
Key secondary outcomes	(1) serum lipids (2) diabetic parameters (3) markers of obesity (4) markers of oxidative stress (5) maekers of chronic kidney diseases/renal injury (6) urate in serum/urine (7) adiposity (8) blood pressures and pulse raate

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Administration of pravastatin
Interventions/Control_2	Administration of ezetimibe
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) Dyslipidemic patients whose LDL-C levels did not reach those recommended by Japan Atherosclerosis Society Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2) Outpatients 3) Subjects who gave written informed consent
Key exclusion criteria	1) Allergy against pravastatin 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	33

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

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 12 Month 16 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	No longer recruiting
Date of protocol fixation	2013 Year 11 Month 11 Day
Date of IRB	2013 Year 11 Month 11 Day
Anticipated trial start date	2013 Year 12 Month 16 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 12 Month 16 Day
Last modified on	2020 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014721