Health Condition 1: null- Mixed dyslipidemia
Conditions
Interventions
Intervention1: FDC 1- Rosuvastatin 5 mg+Fenofibrate 160 mg,: OD for 12 weeks
Intervention2: FDC 2-Rosuvastatin 10 mg+Fenofibrate 160 mg,: OD for 12 weeks
Intervention3: FDC 3-Rosuvastatin 20 mg+Fenofi
20mg): OD for 12 weeks
Sponsors
Biocon Ltd. 20th km, Hosur Road, Electronics City, Bangalore 560100, Karnataka State, India
Bioequivalence Study Centre, Dept. of Pharmaceutical Technology, Jadavpur University, Kolkata-700032.
TAAB Biostudy Services, 27, Central Road, Jadavpur, Kolkata-700032
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients in the age group of 20-80 years 2. Subjects willing to give informed consent. 3. Patients with mixed dyslipidemia. The patients can be anti-lipid drug therapy naïve patients as well Statin treated patients. 4. Patients who were willing to comply with all study requirements
Exclusion criteria
Exclusion criteria: 1. Subjects who were currently participating or had participated in other interventional study the last 3 months prior to their enrolment. 2. Women who were pregnant, breast feeding or had the intention of becoming pregnant during their participation in the study. 3. Women of childbearing potential who were not using effective and medically acceptable methods of contraception. 4. Subjects who were meeting any of the contraindications of the study medication according to the approved SPC. 5. Known CVD, triglycerides > 500 mg/dL, renal disease (serum creatinine levels > 1.6 mg/dL), hypothyroidism [thyroid stimulating hormone (TSH) > 5 IU/mL], liver disease (ALT and/or AST levels > 3-fold upper limit of normal in more than 2 consecutive measurements), alcohol consumption > 3 drinks/day for men and > 2 drinks/day for women, and current or previous gout. 6. Patients with diabetes will be included in the study if they are adequately controlled (HbA1c<7%) with one or 2 antidiabetic drugs (no change in their treatment will be made during the study period). 7. Patients with hypertension will be included in the study if they are on stable medication for at least 3 months and their blood pressure is adequately controlled (no change in their treatment will be made during the study period). 8. Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, psychiatric, or hematological disease as determined by the clinical judgment of the investigator; 9. Use of any investigational drug or participation of any clinical trial within 30 days prior to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in LDL-C for Biocon`s FDC Rosuvastatin and Fenofibrate vs. Rosuvastatin monotherapy and fibrate monotherapy after 3 months of treatment.Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients reaching the LDL-C target levels as per the NCEP ATP III Guideline at the end of 3 months treatment in Biocon`s FDC Rosuvastatin and Fenofibrate vs. statin monotherapy and fibrate monotherapy.Timepoint: 3 months;To compare the percentage change in HDL-C, total cholesterol (TC) and fasting triglycerides (TG) levels from the baseline to end of 3 months therapy with Biocon`s FDC Rosuvastatin and Fenofibrate vs. statin monotherapy and fibrate monotherapy.Timepoint: 3 months;To compare the safety and tolerability of FDC by observing adverse events, changes in laboratory safety variables and discontinuations in Biocon`s FDC Rosuvastatin and Fenofibrate vs. statin monotherapy and fibrate monotherapyTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactProf.(Dr.) Tapan Kumar Pal
Outcome results
None listed