UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of anti-PCSK9 antibody Alirocumab on lipid-lowering on patient motivation to treatment for hypercholesterolemia.
Title of the study (Brief title)	Impact of Alirocumab on patient motivation to treatment.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the impact of Alirocumab on lipid-lowering on patient satisfaction and motivation to treatment in patient with hypercholesterolemia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in patient satisfaction and motivation to treatment from baseline to follow-up as scored using questionnaire.
Key secondary outcomes	glucose(fasting), HbA1c,AST,ALT,gamma-GTP,BUN,Cr,CK,TC,LDL-C,HDL-C,TG,Na,K,Cl,Lp(a),hs-CRP Carotid artery ultrasound,PWV

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	To administrate Alirocumab to patients who have inadequate management of LDL-C levels on maximum tolerated dose
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with Type1 or Type2 diabetes mellitus 2)Patients with heterozygous familial hypercholesterolemia or hypercholesterolemia at high-cardiovascular risk,who have inadequate management of LDL-C levels on maximum tolerated dose of statin 3)Patients aged equal or over 20 years
Key exclusion criteria	1)Pregnant 2)Drug allergy to Alirocumab 3)Unsuitable patients for this study by physicians decision
Target sample size	10

Research contact person
Name of lead principal investigator	Yasuro Kumeda
Organization	Minamiosaka Hospital
Division name	Department of Internal Medicine
Address	1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
TEL	06-6685-0221
Email	y_kumeda@yahoo.co.jp

Public contact
Name of contact person	Yuji Kawaguchi
Organization	Minamiosaka Hospital
Division name	Department of Internal Medicine
Address	1-18-18, Higashikagaya, Suminoe-ku, Osaka, 559-0012, Japan
TEL	06-6685-0221
Homepage URL
Email	y.kawaguchi@minamiosaka.com

Sponsor
Institute	Minamiosaka Hospital Department of Internal Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 10 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 09 Month 26 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 27 Day
Last modified on	2017 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033489