An Observational Post Marketing study to check the safety and tolerance of Atorsave D on patients with hyperlipidemia or statin related myalgia.
- Conditions
- Health Condition 1: I998- Other disorder of circulatory systemHealth Condition 2: null- Patients with hyperlipidemia or statin related myalgia
- Registration Number
- CTRI/2017/09/009644
- Lead Sponsor
- Eris Life sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Men or Women, between 18 to 89 years of age (both inclusive).
2.Patients who have been prescribed statins OR who have had a recent increase in statin dose (in the last seven days) OR with statin intolerance and complaints of myalgia
3.Patient indication and disease condition according to the â??INDICATION & USAGEâ?? as mentioned in the package insert available with Atorsave D
4.Women of childbearing potential using an acceptable method of birth control.
5.Willing to give written informed consent for participation in the study and to comply with the study procedures
1.Evidence of active liver disease or SGPT > 2.5 times upper limit of normal (ULN)
2.Creatinine phosphokinase Total (CPK-T) elevation more than 3 times the ULN
3.Evidence of renal impairment (Serum creatinine levels more than 2.0 mg /dl)
4.Pregnancy
5.Malignancy
6.Contraindication as mentioned in package insert
7.Patients with medical conditions that preclude the follow-up as defined in the protocol or otherwise limits participation in this study
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To explore the overall safety profile of Atorsave D, as measured by adverse events and Questionnaires, in patients with hyperlipidemia or statin under conditions of routine medical practice.Timepoint: Not Applicable
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable