Evaluation of Pitavastatin for efficacy and safety in Dyslipidemic patients:A comparative randomized controlled trial.

A prospective, controlled, randomized, double blind, comparative, parallel, 2-arm study to evaluate the efficacy and safety of Pitavastatin (4 mg) Vs. Atorvastatin (20 mg) in Dyslipidemic patients associated with hypertension, diabetes and / coronary artery disease.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/09/004003

Enrollment

100

Registered

2013-09-19

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- Dyslipidemic patients having hypertension, diabetes and / or coronary artery disease

Interventions

Intervention1: Pitavastatin: 4mg Tablet Once daily before lunch for 8 weeks Orally Control Intervention1: Atorvastatin: Tablet 20 mg 1 tablet Once daily before meals for 8 weeks Orally

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients suffering from Dyslipidemia according to NCEP ATP III Guidelines (National Cholesterol Education Program, Adult Treatment Panel III) (LDL-C greater than or equal to 130 mg/dl, Total cholesterol- TC greater than or equal to 240 mg/dl) and associated with hypertension, diabetes and / coronary artery disease only. 2. Dyslipidemic patients, newly diagnosed or uncontrolled on monotherapy , 3. Non-pregnant, non-lactating female 4. Have given informed consent.

Exclusion criteria

Exclusion criteria: 1. History of muscular or neuromuscular disease of any type 2. H/O chronic liver diseases 3. Impaired renal function 4. Concomitant medications such a cyclosporine A, gemfibrozil, clarithromycin, rafamycin, rafampicin, which might significantly cause drug-drug interaction. 5. History of drug allergy to study drugs related group 6. History of HIV infection 7. Diagnosed case any malignant condition, psychiatric illness 8. Patients addicted to alcohol 9. Exposure to any investigational new drug within 30 days of study entry or ingestion of any drug known to be toxic to a major organ system. 10. Serum total creatine kinase > 5x

Design outcomes

Primary

Measure	Time frame
Percentage Change From Baseline Low Density Lipoprotein Cholesterol(LDL-C)Timepoint: Day 0, day 28 and day 56	—

Secondary

Measure	Time frame
Assessment of adverse events and serious adverse eventsTimepoint: As and when they occur;Change From Baseline in Total Cholesterol (TC) Timepoint: Day 0, day 28 and day 56;Laboratory ParametersTimepoint: Day 0, day 28 and day 56;Percentage Change From Baseline High Density Lipoprotein Cholesterol(HDL-C)Timepoint: Day 0, day 28 and day 56;Percentage Change From Baseline triglyceride (TG) Timepoint: Day 0, day 28 and day 56;Percentage change in baseline LDLC/HDLC ratioTimepoint: Day 0, day 28 and day 56	—

Measure

Time frame

Assessment of adverse events and serious adverse eventsTimepoint: As and when they occur;Change From Baseline in Total Cholesterol (TC) Timepoint: Day 0, day 28 and day 56;Laboratory ParametersTimepoint: Day 0, day 28 and day 56;Percentage Change From Baseline High Density Lipoprotein Cholesterol(HDL-C)Timepoint: Day 0, day 28 and day 56;Percentage Change From Baseline triglyceride (TG) Timepoint: Day 0, day 28 and day 56;Percentage change in baseline LDLC/HDLC ratioTimepoint: Day 0, day 28 and day 56

—

Countries

India

Contacts

Public ContactDr Chetan Yuvraj Patil

Government medical college Aurangabad

doifode.sm@gmail.com9422202625

Outcome results

None listed

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