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

Phase 4

• Conditions: Health Condition 1: null- Dyslipidemic patients having hypertension, diabetes and / or coronary artery disease

• Registration Number: CTRI/2013/09/004003
• Lead Sponsor: Dr Chetan Yuvraj Patil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assessment of adverse events and serious adverse eventsTimepoint: As and when they occur;Change From Baseline in Total Cholesterol (TC) <br/ ><br> <br/ ><br>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) <br/ ><br>Timepoint: Day 0, day 28 and day 56;Percentage change in baseline LDLC/HDLC ratioTimepoint: Day 0, day 28 and day 56