UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000586 |
|---|---|
| Receipt number | 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 10:31:34 |
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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
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
keita@adm.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University School of Medicine Department of Cardiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000711
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