Health Condition 1: null- primary dyslipidemia
Conditions
Interventions
Intervention1: Hydroxychloroquine Plus Atorvastatin: 200mg+10mg for 24 weeks
Control Intervention1: Atorvastatin: 10mg for 24 weeks
Sponsors
Ipca Laboratories Ltd Mumbai
Eligibility
Inclusion criteria
Inclusion criteria: -Treatment naïve 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) OR - 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)
Exclusion criteria
Exclusion criteria: -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 - Patients with abnormal renal and liver function test - Patients receiving non selective beta blocker - Patients with disease of blood or haematopoetic organs -Patients with tuberculosis, terminal cancer, severe dementia, or subjects with history of concomitant infection that could interfere with evaluation. -Woman of childbearing potential who do not agree to practice an effective method of birth control until one month following study completion. -Lactating woman and postmenopausal woman on hormone replacement therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in LDL, TC, TG, HDL from baseline to week 4, week 8, week 12, week16, week 20 and (week 24)end of the study duration (Week 12)Timepoint: Week 4, Week 8, week 12, week 16, week 20 & Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1C changeTimepoint: week 12 and week 24 from baseline;Percentage change in hs- C reactive proteinTimepoint: at week 24 visit from baseline;Percentage change in the lipid levels between both the treatment groups Timepoint: week 4, week 8, week 12, week 16, week 20, week 24 from baseline | — |
Countries
India
Contacts
Public ContactNitin Chandurkar
Outcome results
None listed