Pure & Cure Healthcare secures CDSCO Panel nod for Phase 4 CT of Ivabradine,Metoprolol Tartrate FDC
New Delhi: Pure & Cure has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase IV clinical trial of the fixed dose combination drug, Ivabradine HCl eq. to Ivabradine 5mg/5mg plus Metoprolol Tartrate 50mg/25mg tablets.
However, this approval is subject to the condition that patient with heart rate more than 70 should be included in the inclusion criteria.
This came after the firm presented the Phase IV CT protocol of the the fixed dose combination of Ivabradine HCl eq. to Ivabradine 5mg/5mg plus Metoprolol Tartrate 50mg/25mg tablets before the committee.
Ivabradine Hydrochloride and Metoprolol Tartrate combination drug is used in the treatment of Angina (heart-related chest pain).The combination works by decreasing the heart rate and thus making the heart more efficient in pumping blood throughout the body. Ivabradine and Metoprolol slow the heart rate individually and thus using them together increased this effect .
Ivabradine is a HCN (Hyperpolarization activated-Cyclic Nucleotide) channel blocker, used to the risk of hospitalization for worsening heart failure in adult patients and for treatment of stable symptomatic heart failure as a result of dilated cardiomyopathy in pediatric patients. Metoprolol Tartrate is a beta-blocker that affects the heart and circulation (blood flow through arteries and veins).
At the SEC meeting for Cardiovascular & Renal held on December 8th & 9th 2022, the expert panel reviewed the Phase IV Ct protocol of the fixed dose combination drug Ivabradine HCl eq. to Ivabradine 5mg/5mg plus Metoprolol Tartrate 50mg/25mg tablets.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase IV CT with condition that patient with heart rate more than 70 should be included in the inclusion criteria.
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