Comparative Evaluation of Efficacy and Safety of Fixed Dose Combination of Atorvastatin and Hydroxychloroquine with Atorvastatin alone in Patients with Dyslipidemia

Ipca Laboratories Ltd Mumbai0 sites328 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

August 11, 2014

Last Updated

4 years ago

Study Type

Interventional

Sponsor

Ipca Laboratories Ltd Mumbai

•Treatment naÃ¯ve patients with primary dyslipidemia and CHD or CHD risk equivalent characterized by an LDL\-C level greater than or equal to 130 and greater than or equal to 250 mg/dL (3\.3 mmol/L\- 6\.46 mmol/L), and TG levels less than or equal to 400mg/dl(4\.51 mmol/L)
•\- Patients receiving prior statin therapy for dyslipidemia ( Atorvastatin not more than 10 mg, simvastatin not more than 20 mg, lovastatin not more than 20 mg, pravastatin not more than 40 mg and rosuvastatin not more than 5 m with LDL\-C grater than or equal to 250 mg/dl (3\.3 mmol/L\- 6\.46 mmol/L), and TG levels greater than or equal to 150 mg/dL(1\.69 mmol/L) and less than or equal to 400 mg/dL (4\.51 mmol/L)

•\-Patients with Type I diabetes.
•\-Patients with Type 2 diabetes characterized by HbA1c less than or equal to 9 .
•\- Patients with severe obesity or body mass index more than 35 kg/m square
•\-Patients with homozygous familial hypercholesterolemia.
•\-Patients with recent cardiovascular accident or myocardial. infarction stroke or has undergone coronary artery bypass surgery, percutaneous tranluminal coronary angioplasty or unstable or severe peripheral artery disease within the past 6 months.
•\-Patients who had any other illness for which hydroxychloroquine was indicated (such as rheumatoid arthritis, Systemic lupus erythomatosus (SLE), malaria etc).
•\- Patients with history of any retinopathy including diabetic retinopathy requiring laser therapy, evidence of an imminent need for retinal laser therapy, uncorrected visual acuityless than 20/100, abnormal visual fields , difficulty to examine optic disc or evidence of retinal pigment epithelial abnormalities and patients with history or risk of macular edema.
•\- Patients with history of myalgia , aplastic anemia or agranulocytosis, granulocytopenia, psoriasis, porphyria, rash, scaling, scaling eczema and G6PD deficiency
•\- Patients with chronic use of non\- steroidal anti inflamentry agents
•\- Patients receiving niacine and fibric acid derivatives