Health Condition 1: null- hyperlipidemia
Conditions
Interventions
Intervention1: Rosuvastatin 5 mg arm: Rosuvas 5mg oral, once daily, for 8 weeks
Intervention2: Rosuvastatin 10 mg arm: Rosuvas 10 mg oral, once daily, for 8 weeks
Intervention3: Rosuvastatin 20 mg arm
Sponsors
Ranbaxy Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subject in the age range of 18-65 years. 2.Subjects with hyperlipidemia defined as fasting LDL cholesterol more than 130 mg/dL who require lipid altering therapy as judged by the treating physician. 3. Patients must be willing to follow the Therapeutic Lifestyle Changes (TLC) diet or similar cholesterol-lowering diet for the duration of the evaluation program. 4. Able to provide written, voluntary informed consent and have accessibility to the site. 5. Should not have received any statin/hypolipidemic therapy in the preceding 3 months at entry into the evaluation program.
Exclusion criteria
Exclusion criteria: 1.Female subject of child bearing potential or male subject who has a partner of childbearing potential, who refuses to use a medically acceptable form of contraception throughout the evaluation program. 2.Female subject who is pregnant or lactating. 3.Known hypersensitivity to Rosuvastatin or components 4.Active liver disease or hepatic dysfunction (defined by an ALT, AST concentration of greater than 1.5 times the upper limit of normal [ULN]), 5.Subjects with renal impairment or at screening presents with serum creatine greater than 1.4 mg/dL. 6.Serum CK concentrations of greater than 3 times the ULN 7.Usage of concomitant medications known to affect the lipid profile or present a potential safety concern (eg, through drug interaction) 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 evaluation, 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 study within 30 days prior to this evaluation program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in LDL-C for each dose group and average reduction across dose groups. Percentage change from baseline in Total cholesterol, HDL-C and Triglycerides Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and type of any clinical or laboratory adverse experiences.Timepoint: 8 weeks;Percentage of subjects achieving NCEP ATP III defined target levels in each dosage groupsTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Navneet Wadhwa
Ranbaxy Laboratories Ltd
Outcome results
None listed