CTRI/2017/09/009644
Completed
Phase 4
A Phase IV, Randomized, Open Label, Multicentre Study to Confirm the Safety and Tolerability of Atorsave D (Atorvastain & Cholecalciferol).
Eris Life sciences Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: I998- Other disorder of circulatory systemHealth Condition 2: null- Patients with hyperlipidemia or statin related myalgia
- Sponsor
- Eris Life sciences Pvt Ltd
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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