To study the effect and safety of hydroxycholoroquine and atorvastatin in patient suffering from high cholesterol and pre diabetes

Phase 3

• Conditions: Health Condition 1: R730- Abnormal glucose

• Registration Number: CTRI/2017/12/010763
• Lead Sponsor: Ipca Laboratories Ltd

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Patients with primary dyslipidemia (LDL-C level >= 130 mg/dL and/or TG levels >=150 mg/dL and <= 400 mg/dL).

2) Patients having HbA1c between 5.7% and 6.4%

3) Patients with body weight > 60 kg

4) Patients able to understand and willing to fully comply with study procedures and

restrictions

5) Patient ready to give written informed consent as per applicable regulatory

requirements

Exclusion Criteria

1) Patients with Type 1 or Type 2 diabetes

2) Patients with a history or presence of any retinopathy of any grade including diabetic

retinopathy requiring laser therapy, evidence of an imminent need for retinal laser

therapy, uncorrected visual acuity <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

3) Patients with abnormal renal function (eGFR <60 mL/min/1.73m2)

4) Patients with abnormal liver function (AST and ALT, total bilirubin, creatine

phosphokinase or alkaline phosphatase >2.5 times the upper limit of normal values)

5) Patients with cardiovascular accident or myocardial infarction, stroke or has

undergone coronary artery bypass surgery, percutaneous transluminal coronary

angioplasty or transient ischemic attack, or history of congestive heart failure, or

unstable angina or edema of any type in past

6) Patients with history of myalgia, aplastic anemia or agranulocytosis,

granulocytopenia, psoriasis, porphyria, rash, scaling, scaling eczema, and G6PD

deficiency

7) Patient with history of symptomatic autonomic neuropathy

8) Patients with disease of blood or haematopoetic organs or hemoglobin < 11g/dL for

female patient or hemoglobin < 13 g/dL for male patient

9) Patients with systolic BP > 180 mm Hg and/or diastolic BP >110 mmHg

10) Patients with chronic gastroparesis, active gastrointestinal disorders (gastric and

duodenal ulcer)

11) Patient who had any other illness for which hydroxychloroquine was indicated (such

as rheumatoid arthritis, SLE).

12) Patients with known history of HIV1/HIV2/Hepatitis B or C infection or syphilis infection

13) Patients with any other clinically significant abnormality (ies) interfering with disease under evaluation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients developing diabetes (HbA1c â?¥ 6.5%)Timepoint: Within 52 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage change in low-density lipoprotein cholesterol <br/ ><br>(LDL-C), total cholesterol (TC), triglycerides (TG), high-density lipoprotein <br/ ><br>cholesterol (HDL-C) and non-high density lipoprotein cholesterol (non-HDL-C)Timepoint: At week 24 and week 52