Health Condition 1: E786- Lipoprotein deficiency
Conditions
Interventions
Intervention1: IN-SUPR-002
[FDC of 135 mg Choline fenofibrate (delayed release) and rosuvastatin 10 mg] capsules: Dose: One capsule orally,
Frequency: Once daily,
Mode of Administration: Oral,
Durati
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Between age of 18 to 70 years 2. Serum triglycerides between 150 mg/dl and 500 mg/dl 3. Serum LDL-C > 100 mg/dl 4. Serum HDL-C 5. 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. Patients with type 1 diabetes mellitus. 3. Patients with thyroid dysfunction. 4. Patients with hypersensitivity to rosuvastatin, fenofibric acid or fenofibrate. 5. Patients who are chronic alcoholic ( > 20 ml of alcohol/day) 6. Patients on treatment of spironolactone and cimetidine 7. Patients with renal dysfunction: Serum creatinine > 1.5 mg/dl.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % Change in serum triglyceridesTimepoint: At the end of study as compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| % Change in LDL-C % Change in HDL-C % Change in total cholesterol % Change in VLDL-CTimepoint: At the end of study as compared to baseline | — |
Countries
India
Contacts
Public ContactMr Harshit Shah
Lambda Therapeutic Research Ltd
Outcome results
None listed