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.

A randomized, double blind, comparative, multicentric study evaluating efficacy and tolerability of Extended Release Niacin and Rosuvastatin vs Matching placebo and Rosuvastatin in patients with Mixed Dyslipidemia.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/091/000030

Enrollment

Registered

2011-01-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Mixed Dyslipidemia

Interventions

Intervention1: Niacin 500 mg Extended Release tablet + Rosuvastatin Tablet: At the beginning of the study all patients receives 500mg of Extended Release Niacin once a day. Dose of Niacin will be grad

Eligibility

Inclusion criteria

Inclusion criteria: 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 4.Patients requiring Rosuvastatin therapy (already receiving Rosuvastatin or recently started)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Vijaya Jaiswal

vijayajaiswal@troikaapharma.com079-26856242

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026