UMIN ID: UMIN000000586
Registered date:01/02/2007
Randomized Head-to-Head Comparatison of Pitavastatin, Atorvastatin and Rosuvastatin for the safety and efficacy (Quantity and Quality of LDL)(PATROL study)
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Patients with elevated LDL-C |
Date of first enrollment | 2007/02/01 |
Target sample size | 300 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Pitavastatin treatment group Atorvastatin treatment group Rosuvastatin treatment group |
Outcome(s)
Primary Outcome | 1.Incidence of adverse drug reactions (ADRs) 2.Change of LDL-C |
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Secondary Outcome | 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 |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude 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 |
Related Information
Primary Sponsor | Fukuoka University School of Medicine Department of Cardiology |
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Secondary Sponsor | |
Source(s) of Monetary Support | None |
Secondary ID(s) |
Contact
public contact | |
Name | Keita Noda |
Address | 7-45-1 Nanakuma Jyonan-ku Fukuoka-shi Fukuoka-ken Japan |
Telephone | 092-801-1011 |
keita@adm.fukuoka-u.ac.jp | |
Affiliation | Fukuoka University hospital Clinical research assist center |
scientific contact | |
Name | Keijiro Saku |
Address | 7-45-1 Nanakuma Jyonan-ku Fukuoka-shi Fukuoka-ken Japan |
Telephone | 092-801-1011 |
Affiliation | Fukuoka University School of Medicine Department of Cardiology |