Evaluation of Efficacy and Safety of Combination of Atorvastatin and Hydroxychloroquine with Atorvastatin alone in Patients with Dyslipidemia
- Conditions
- Health Condition 1: null- primary dyslipidemia
- Registration Number
- CTRI/2010/091/006138
- Lead Sponsor
- Ipca Laboratories Ltd Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 328
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)
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 <br/ ><br>Timepoint: week 4, week 8, week 12, week 16, week 20, week 24 from baseline