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Post marketing surveillance study of Pitavastatin for evaluation of its safety and efficacy in patients with diabetes and high cholesterol

A Post Marketing Surveillance study to assess the efficacy and safety of PIVASTA (Pitavastatin) Tablets in patients of Type 2 Diabetes mellitus and dyslipidemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2013/05/003686
Enrollment
500
Registered
2013-05-27
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- Diabetic Dyslipidemia

Interventions

Intervention1: pitavastatin: one/two Pitavastatin 2 mg tablets per day preferably in the morning for 12 weeks

Sponsors

Cadila Healthcare
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex, 18-75 years of age.. 2. Patients who are diagnosed of Type 2 Diabetes 3. Patients with any one of the following: serum Low density Lipoprotein (LDL) cholesterol > 100 mg/dl, Or serum high density lipoprotein (HDL) cholesterol 150 mg/dl

Exclusion criteria

Exclusion criteria: Patients who is: 1. Known to have hypersensitivity to pitavastatin 2. Having active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels 3. Pregnant woman or may become pregnant in next 3 months 4. Nursing mother 5. on cyclosporine 6. Has change/titration in anti-diabetic medications in last one month 7. On statin or other lipid lowering therapy during last 3 months 8. creatinine clearance 9. not willing to give written consent for enrollment in the study.

Design outcomes

Primary

MeasureTime frame
Change in the serum LDL cholesterol levels compared to baseline levels. Timepoint: Change in the serum LDL cholesterol levels compared to baseline levels.

Secondary

MeasureTime frame
Change in the serum total cholesterol levels at 3 months compared to baseline levels. Change in the serum HDL cholesterol levels at 3 months compared to baseline levels. Change in the serum Triglycerides levels at 3 months compared to baseline levelsTimepoint: At 3 months

Countries

India

Contacts

Public ContactDr Samir Prajapati

Cadila Healthcare

samirprajapati@zyduscadila.com08128674594

Outcome results

None listed

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