Modify phase IV CT Protocol: CDSCO panel Tells Akums Pharma on FDC Bempedoic acid, Rosuvastatin Calcium
New Delhi: After reviewing the Phase IV clinical trial protocol of the fixed-dose combination Bempedoic acid plus Rosuvastatin Calcium presented by the drug major Akums Drugs and Pharmaceuticals, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the firm to modify and submit the revised Phase IV clinical trial protocol.
This came after the firm presented the Phase IV clinical trial protocol before the committee.
Regarding the modification, the expert panel suggested to the firm that inclusion criteria should be modified by including LFT, Lipid Profile, Serum Creatinine, and Spot Urine Protein Creatinine Ratio (PCR).
Furthermore, the committee stated that adequate time needs to be mentioned in the methodology to see the effects of the maximum tolerated dose of Atorvastatin 80 mg and Rosuvastatin 40 mg.
In addition, the expert panel advised including more government sites which should be geographically distributed so that there should be 50% each from Government and Private sites
In continuation, the expert panel suggested the firm recalculate the sample size based on relevant literature specific to the study protocol.
Bempedoic acid is a novel nonstatin drug that inhibits cholesterol biosynthesis in the same pathway as statins. It is administered as a prodrug and is only converted to an active drug in the liver and not the muscles.
Bempedoic acid works by blocking an enzyme (adenosine triphosphate-citrate lyase) that is required to make “bad” cholesterol (low-density lipoprotein) in the liver, which results in lower levels of "bad" cholesterol.
Rosuvastatin is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, and triglycerides) and raise "good" cholesterol (HDL) in the blood. It belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps to prevent strokes and heart attacks.
At the recent SEC meeting for the Cardiovascular and Renal held on the 7th of November 2023, the expert panel reviewed the Phase IV clinical trial protocol of the FDC Bempedoic acid plus Rosuvastatin Calcium.
After detailed deliberation, the committee opined the following modification to the clinical trial Protocol:
1. Inclusion criteria should be modified by including LFT, Lipid Profile, Serum Creatinine, and Spot Urine Protein Creatinine Ratio (PCR).
2. Adequate time needs to be mentioned in the methodology to see the effects of the maximum tolerated dose of Atorvastatin 80 mg and Rosuvastatin 40 mg.
3. More government sites to be included which should be geographically distributed so that there should be 50% each from Government and Private sites.
4. Recalculate the sample size based on relevant literature specific to the study protocol.
Accordingly, the expert panel suggested that the revised Phase IV clinical trial protocol should be submitted to CDSCO for further review by the committee.
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