Post marketing surveillance study of Pitavastatin for evaluation of its safety and efficacy in patients with diabetes and high cholesterol
- Conditions
- Health Condition 1: null- Diabetic Dyslipidemia
- Registration Number
- CTRI/2013/05/003686
- Lead Sponsor
- Cadila Healthcare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
1. Patients of either sex, 18-75 years of age..
2. Patients who are diagnosed of Type 2 Diabetes
3. Patients with any one of the following: serum Low density Lipoprotein (LDL) cholesterol > 100 mg/dl, Or serum high density lipoprotein (HDL) cholesterol < 40 mg/dl (for male), HDL < 50 mg/dl (for female), Or serum triglycerides (TG) > 150 mg/dl
Patients who is:
1. Known to have hypersensitivity to pitavastatin
2. Having active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
3. Pregnant woman or may become pregnant in next 3 months
4. Nursing mother
5. on cyclosporine
6. Has change/titration in anti-diabetic medications in last one month
7. On statin or other lipid lowering therapy during last 3 months
8. creatinine clearance < 30 ml/min/1.73 m2
9. not willing to give written consent for enrollment in the study.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method