A clinical study to evaluate the efficacy, safety and tolerability of Rosuvastatin 10 mg plus Fenofibrate 160 mg tablet Vs Atorvastatin 10 mg plus Fenofibrate 160 mg Tablet in patients with dyslipidaemia.

A comparative, randomized, open label, parallel group, and multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Rosuvastatin 10 mg plus Fenofibrate 160 mg tablet Vs Atorvastatin 10 mg plus Fenofibrate 160 mg Tablet in patients with dyslipidaemia.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001294

Enrollment

200

Registered

2010-09-14

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- Dyslipidaemia Health Condition 2: E788- Other disorders of lipoprotein metabolism

Interventions

Intervention1: Rosuvastatin plus Fenofibrate tablets: Once daily for 12 week Control Intervention1: Atorvastatin plus Fenofibrate Tablet: Once daily for 12 week

Eligibility

Inclusion criteria

Inclusion criteria: 1.Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent 2.Patient with LDL-cholesterol ≥ 145 mg/dl (3.75mmol/l) and ≤ 250 mg/dl (6.47mmol/l) and triglyceride ≤ 350 mg/dl 93.99 mmol/l)

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity to the study drug or similar class of drug. 2. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. 3. Pregnant or lactating women. 4. Patients with serum creatinine greater than 2.5 mg/dl. 5. Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits 6. History of drug dependency, alcohol abuse, or serious neurological or psychological disease. 7. Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study. 8. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study. 9. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study

Design outcomes

Primary

Measure	Time frame
LDL-cholesterolTimepoint: Day 1,Week 4, Week 8 and Week 12	—

Secondary

Measure	Time frame
Global assessment by the patients and investigatorsTimepoint: 12th week;HDL cholesterolTimepoint: Day 1, Week 4, Week 8 and week 12;Total cholesterolTimepoint: Day 1, Week 4, Week 8 and week 12;TriglycerideTimepoint: Day 1, Week 4, Week 8 and week 12	—

Countries

India

Contacts

Public ContactDr Shailesh Singh

Ajanta Pharma Ltd, Advent

shailesh.singh@ajantapharma.com02266062111

Outcome results

None listed

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