Health Condition 1: null- patients with hyperlipidemia
Conditions
Interventions
Intervention1: FDC of Atorvastatin (10/20 mg) and Vitamin D3 (1000 IU): Route of Administration: Oral
Total Duration of therapy: 24 weeks
Control Intervention1: Atorvastatin (10/20 mg): Route of Ad
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female patients aged between 18 to 70 years with hyperlipidemia. 2 Patients LDL level greater than or equal to 100 mg/dL with at least one risk factor OR LDL level greater than or equal to 130 mg/dL with no risk factor. 3 Treatment-Naïve Patients i.e., not currently on Statin or other Lipid lowering drugs or Vitamin D supplement. 4 Patients willing to give their informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control. 2. Patient whose serum level of Vitamin D3 3. Patients with cardiovascular disease and/or type 1 diabetes mellitus. 4. Patients with significantly abnormal laboratory analysis of thyroid function. 5. Patients with severe renal impairment, including those receiving dialysis. 6. Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities. 7. Patients with preexisting gallbladder disease. 8. Patients who is taking seizure drugs. 9. Patients who is taking steroids. 10. Patients with hypersensitivity to statin. 11. Patients taking oral coumarin anticoagulant. 12. Patients with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP 3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole). 13. Patient with history of alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Evaluation of Percent average change of LDL from baseline to end of treatment â?¢ Evaluation of Percent average change of TC from baseline to end of treatment Timepoint: Visit 01 (Day 0), Visit 02 (Day 56 ± 2), Visit 03 (Day 112 ± 2), ), Visit 04 (Day 168 ± 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of laboratory parameters from baseline to end of treatment (Hemoglobin, Total and differential WBC count, SGOT, SGPT, Total bilirubin, Serum Creatinine and urine analysisTimepoint: Visit 01 (Day 0) and Visit 04 (Day 168 ± 2);ECG assessment at baseline and end of the treatmentTimepoint: Visit 01 (Day 0) and Visit 04 (Day 168 ± 2);Evaluation of Percent average change of HDL from baseline to end of treatmentTimepoint: Visit 01 (Day 0), Visit 02 (Day 56 ± 2), Visit 03 (Day 112 ± 2), Visit 04 (Day 168 ± 2);Evaluation of Percent average change of TG from baseline to end of treatmentTimepoint: Visit 01 (Day 0), Visit 02 (Day 56 ± 2), Visit 03 (Day 112 ± 2), Visit 04 (Day 168 ± 2);Evaluation of Percent average change of Vitamin D3 level from baseline to end of treatmentTimepoint: Visit 01 (Day 0) and Visit 04 (Day 168 ± 2);Treatment Emergent AEs (Adverse Events) / monitoring of AEs and SAEs (Serious Adverse Events) throughout the study periodTimepoint: Visit 02 (Day 56 ± 2), Visit 03 (Day 112 ± 2), Visit 04 (Day 168 ± 2) | — |
Countries
India
Contacts
Public ContactMr Guruprasad Palekar
Sun Pharma Laboratories Limited
Outcome results
None listed