To determine the efficacy and safety of a combination of Extended Release (ER) Niacin and Rosuvastatin as compared with Matching placebo and Rosuvastatin in patients with Mixed Dyslipidemia.
- Conditions
- Health Condition 1: null- Mixed Dyslipidemia
- Registration Number
- CTRI/2011/091/000030
- Lead Sponsor
- Troikaa Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 60
1.Patients in the age group of 18-75 years suffering from Mixed dyslipidemia
2.Patients with LDL-C level > 130 mg/dL
3.Patients with HDL-C level < 40 mg/dL
4.Patients requiring Rosuvastatin therapy (already receiving Rosuvastatin or recently started)
1.Patient with history of hypersensitivity to any statin, niacin or aspirin
2.Patients with uncontrolled diabetes
3.Patients with clinically unacceptable laboratory parameters
4.Patients with peptic ulcer disease
5.Patients with history of bleeding or coagulation disorder
6.Patients requiring hospitalization
7.Patient with history of hypotension
8.Patients with compromised hepatic and renal function
9.Pregnant and lactating women
10.Women of child bearing age not practicing or not willing to use contraceptive
11.Patients experiencing post menopausal hot flashes
12.Mentally retarded patients
13.Patients not willing to sign written informed consent
14.Patients receiving hormone replacement therapy, high dose of antioxidant vitamin therapy or systemic corticosteroid therapy
15.Patients requiring concomitant therapy with other lipid lowering drugs
16.Patients who participated in clinical trial with in 30 days before enrollment into the study
17.Patients, for any reason who are considered to be unsuitable candidates by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in lipid profile (TC, LDL-C, HDL-C and TG)Timepoint: Baseline Visit, 3rd Visit & End of Study Visit;Change in lipid profile (TC, LDL-C, HDL-C and TG)Timepoint: Baseline Visit, 3rd Visit & End of Study Visit;Change in lipid profile (TC, LDL-C, HDL-C and TG)Timepoint: Baseline Visit, 3rd Visit & End of Study Visit
- Secondary Outcome Measures
Name Time Method Drop out rate because of flushingTimepoint: During entire Study Period;Median duration of flushingTimepoint: During Entire Study Period;Median time for flushingTimepoint: During Entire Study Period