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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000586
Receipt No. R000000711
Scientific Title Randomized Head-to-Head Comparatison of Pitavastatin, Atorvastatin and Rosuvastatin for the safety and efficacy (Quantity and Quality of LDL)(PATROL study)
Date of disclosure of the study information 2007/02/01
Last modified on 2010/07/29

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Basic information
Public title Randomized Head-to-Head Comparatison of Pitavastatin, Atorvastatin and Rosuvastatin for the safety and efficacy (Quantity and Quality of LDL)(PATROL study)
Acronym Randomized Head-to-Head Comparatison of Pitavastatin, Atorvastatin and Rosuvastatin for the safety and efficacy(PATROL study)
Scientific Title Randomized Head-to-Head Comparatison of Pitavastatin, Atorvastatin and Rosuvastatin for the safety and efficacy (Quantity and Quality of LDL)(PATROL study)
Scientific Title:Acronym Randomized Head-to-Head Comparatison of Pitavastatin, Atorvastatin and Rosuvastatin for the safety and efficacy(PATROL study)
Region
Japan

Condition
Condition Patients with elevated LDL-C
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate of the safety of 4 months of treatment with pitavastatin, atorvastatin and rosuvastatin in doses sufficient to achieve a specified LDL-C goal (JAS guideline)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Incidence of adverse drug reactions (ADRs)
2.Change of LDL-C
Key secondary outcomes 1.Incidence of adverse events (AEs)
2.Incidence of abnormal laboratory test values and ADRs associated with abnormal laboratory test values
3.Number of AEs and ADRs
4.Change of laboratory test values
5.Discontinuation related ADRs
6.Incidence of abnormal laboratory test values and ADRs associated with abnormal laboratory test values related hepatic function, renal function and the musculo-skeletal system
7.Classification of ADRs related hepatic and renal function based on CTCAE v3.0
8.Classification of ADRs related to the musculo-skeletal system based on grade classification published by Ministry of Health, Labour and Welfare
9.Change of HDL-C
10.Change of triglyceride
11.Change of HDL-C/LDL-C ratio
12.Percent patients reaching the LDL-C goal
13.Change of charge modified LDL
14.Change of LDL particle number
15.Change of small dense LDL
16.Change of hs-CRP

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pitavastatin treatment group
Interventions/Control_2 Atorvastatin treatment group
Interventions/Control_3 Rosuvastatin treatment group
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 elevated LDL-cholesterol
Inclusion criteria
1)Patients with LDL-C >= 140mg/dL
2)Patients who are unable to reach LDL-C goal (JAS)
2.Patients who meet the criteria for inclusion and written informed consent to participate.
3.Outpatients(Age >= 20 years old)
4.Male or Female
Key exclusion criteria 1.Familial hypercholesterolemia
2.Uncontrolled diabetic patients defined as HbA1c>8.0%
3.Uncontrolled thyroid disorder patients
4.Severe hepatic disorders or biliary atresia(ALT,AST >= 2 times the upper limit of normal)
5.CK(CPK)>2 times the upper limit of normal
6.Nephrotic syndrome or severe renal disorder defined as serum creatinine >=2.0 mg/dl
7.Myocardial infarction within the previous six months
8.Stroke occurred within six months
9.A history of malignant tumor within 5 years of enrollment or suspicion of present malignancy
10.Patients with a history of hypersensitivity to statins
11.Patients who have ever discontinued administration of study drugs
12.Pregnant and potential pregnancy
13.Patients judged as being inappropriate for the study by investigators
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keijiro Saku
Organization Fukuoka University School of Medicine
Division name Department of Cardiology
Zip code
Address 7-45-1 Nanakuma Jyonan-ku Fukuoka-shi Fukuoka-ken
TEL 092-801-1011
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keita Noda
Organization Fukuoka University hospital
Division name Clinical research assist center
Zip code
Address 7-45-1 Nanakuma Jyonan-ku Fukuoka-shi Fukuoka-ken
TEL 092-801-1011
Homepage URL
Email keita@adm.fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University School of Medicine Department of Cardiology
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)

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
2007 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2007 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2009 Year 02 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 02 Month 01 Day
Date analysis concluded
2010 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 01 Month 29 Day
Last modified on
2010 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000711

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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