A Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Atorvastatin 20 mg & Pioglitazone 30 mg Tablets Vs Atorvastatin Tablets 20 mg in Patients with Hypercholesteremia.

A Comparative, Randomized, Single Blind, Multicentric, Prospective Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Atorvastatin 20 mg & Pioglitazone 30 mg Tablets Vs Atorvastatin Tablets 20 mg in Patients with Hypercholesteremia.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000431

Enrollment

200

Registered

2010-04-28

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- Hypercholesteremia Health Condition 2: E780- Pure hypercholesterolemia

Interventions

Intervention1: Atorvastatin 20 mg &amp

Pioglitazone 30 mg Tablets: Once daily for a period of 12 weeks Control Intervention1: Atorvastatin Tablets 20 mg: Once daily for a period of 12 weeks

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

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. HIV and Australian Antigen positive subjects. 10. 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: 0th day, 4th week, 8th week and 12th week	—

Secondary

Measure	Time frame
Global assessmentTimepoint: 12th week;HDL cholesterolTimepoint: 0th day, 4th week, 8th week and 12th week;Safety and TolerabilityTimepoint: 0th day, 4th week, 8th week and 12th week;Total cholesterolTimepoint: 0th day, 4th week, 8th week and 12th week;TriglycerideTimepoint: 0th day, 4th week, 8th week and 12th week	—

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