UMIN ID: C000000328
Registered date:01/03/2006
Nippon Medical School- Tohoku University Graduate School Intervention with Pitavastatin: Study for hypercholesterolemia with type 2 diabetes mellitus.
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Hypercholesterolemic patients with type 2 diabetes mellitus |
| Date of first enrollment | 2006/03/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Pitavastatin 1 mg or 2 mg daily for a period of 36 months Pravastatin 10 mg daily for a period of 36 months |
Outcome(s)
| Primary Outcome | A change of intima-media thickness (IMT)of common carotid artery |
|---|---|
| Secondary Outcome | A change of the following items (1)Serum lipid profile (LDL-C, triglyceride, HDL-C) (2)Atherosclerosis-related markers (adiponectin, hsCRP, PCOOH, urinary 8-OH-dG) (3)LPL mass (4)Plasma glucose (fasting plasma glucose, HbA1c) (5)Microalbuminuria Evaluation of adverse events and laboratory test abnormalities |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1)Uncontrolled diabetes mellitus (HbA1c >/= 8.0%). (2)Known hypersensitivity or history of clinically significant adverse reactions to any component of drugs. (3)Have serious hypertension (systolic blood pressure >/= 180 mmHg, or diastolic blood pressure >/= 110 mmHg) (4)History of stroke, myocardial infarction (observed within the immediate 3 months prior to screening) or heart failure. (5)Patients with serious renal disfunction or serum creatinine more than 1.5 mg/dL. (6)Patients who are relevant to contraindications listed in statin labellings. * Patients with serious liver dysfunction or biliary obstruction. * Patients who are being treated with cyclosporine. * Pregnant, possibly pregnant, or lactating. * Patients, taking fibrates, with laboratory test abnormalities in renal function. |
Related Information
| Primary Sponsor | Dyslipidemia with diabetes study group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Dyslipidemia with diabetes study group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yasushi Ishigaki |
| Address | 2-1, SEIRYO-CHO, AOBAKU, SENDAI, MIYAGI 980-8575 Japan |
| Telephone | 022-717-7611 |
| yishigaki@int3.tohoku.ac.jp | |
| Affiliation | Dyslipidemia with diabetes study group Molecular Metabolism and Diabetes, Tohoku University, Graduate School of Medicine |
| scientific contact | |
| Name | Yoshitomo Oka |
| Address | 2-1, SEIRYO-CHO, AOBAKU, SENDAI, MIYAGI 980-8575 Japan |
| Telephone | 022-717-7611 |
| Affiliation | Tohoku University, Graduate School of Medicine Molecular Metabolism and Diabetes |