Study of effects of different doses of atorvastatin on lipid lowering in patients with high lipid levels

Phase 4

Completed

• Conditions: Health Condition 1: null- Dyslipidemia

• Registration Number: CTRI/2011/12/002216
• Lead Sponsor: Jawaharlal Nehru Medical College

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: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1.Patients >=18 years of age of either sex

2.Patients willing to give written informed consent.

3.Dyslipidemic patients eligible for lipid lowering therapy at baseline, as determined by NCEP-ATP III (National Cholesterol education program - Adult Treatment Panel III) guidelines.

• < 2 risk factors for CHD, LDL >=160 mg/dL

•>= 2 risk factors that confer a 10-year risk for CHD of <10%, LDL >=160 mg/dL

•>=2 risk factors that confer a 10-year risk for CHD of 10% to 20%, LDL >=130 mg/dL

• >=2 risk factors that confer a 10-year risk for CHD of >20%, LDL >=100 mg/dL

4. Patients willing to adhere to a low fat diet as advised by the study investigator

Exclusion Criteria

1.Patients with history or clinical evidence of myocardial infarction, unstable angina, stable angina, coronary artery procedures (angioplasty or bypass surgery), or evidence of clinically significant myocardial ischemia.

2.Patients with history or clinical evidence of non-coronary forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease, transient ischemic attacks or stroke of carotid origin or 50% obstruction of carotid artery)

3.Patients with uncontrolled diabetes (i.e. fasting blood sugar > 140 mg/dL) or uncontrolled hypertension( diastolic blood pressure >95 mm Hg)

4.Impaired hepatic function (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >=2 Ã? the upper limit of normal [ULN])

5.Patients with current use of lipid lowering drugs (e.g., bile acid sequestrant, fibrate, nicotinic acid, fish oil), CYP 3A4 inhibitor (including cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, macrolide antibiotics) or oral corticosteroid

6.Intolerance to statins at any time in the past

7.Recent major surgery/illness/tissue injury/ muscle injury/ extensive burns

8.Family history or past history of muscular disorders

9.Excessive physical exercise of any form

10.Patients who have experienced any unexplained muscle pain, tenderness or weakness in the past

11.Decompensated hepatic / renal / GIT/ respiratory / haematological / infectious / metabolic / hormonal / autoimmune disorders

12.Pregnant / Lactating mothers and women of childbearing potential not using medically accepted methods of contraception.

13.Active alcohol intake

14.Drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance.

15. Participation in any clinical trial in the last 6 months

16.Any serious or unstable medical or psychological condition that in the opinion of the investigator would compromise the patients safety or successful participation in the trial for e.g. physical examination, laboratory test, ECG, e.t.c.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Percent change from baseline in LDL cholesterol [ Time Frame: After 4 weeks and 12 weeks on study drug ] <br/ ><br>â?¢Percentage of subjects who reach LDL goals as per NCEP - ATP III guidelines [ Time Frame: After 12 weeks of study drug ]Timepoint: â?¢Percent change from baseline in LDL cholesterol [ Time Frame: After 4 weeks and 12 weeks on study drug ] <br/ ><br>â?¢Percentage of subjects who reach LDL goals as per NCEP - ATP III guidelines [ Time Frame: After 12 weeks of study drug ]

Secondary Outcome Measures

Name	Time	Method
3. Health Related Quality of life (HRQOL) score evaluation using SF-36, 36-Item Health Survey questionnaire. <br/ ><br>4. Evaluate safety by assessing the laboratory parameters and treatment emergent adverse events.Timepoint: 3. Time Frame: Before and at the end of the study after 12 weeks of study drug <br/ ><br>4. Time Frame: Every 15 days from the onset of the study to the end