AstraZeneca gets CDSCO panel Nod To study antihypertensive drug Baxdrostat
New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III Clinical study of antihypertensive drug, Baxdrostat Tablets 1mg/ 2mg/Placebo.However, this approval is subject to the condition that at least 50% of trial sites should be govt. sites and at least 50%...
New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III Clinical study of antihypertensive drug, Baxdrostat Tablets 1mg/ 2mg/Placebo.
However, this approval is subject to the condition that at least 50% of trial sites should be govt. sites and at least 50% of subjects shall be enrolled from govt. sites.
In addition, the expert panel suggested that investigators in the study should be cardiologists only. Furthermore, it is stated that the co-medication and other treatments including follow should be borne by the sponsor.
This came after the firm presented Phase III Clinical Study Protocol No. D6970C00002.
Baxdrostat is a selective aldosterone synthase inhibitor that significantly lowers blood pressure in patients with resistant hypertension. Baxdrostat targets aldosterone synthase, encoded by the CYP11B2 gene. Importantly, the drug has a low affinity for the enzyme responsible for cortisol synthesis, which is also encoded by the CYP11B1 gene.
At the recent SEC meeting for the Cardiovascular and Renal held on 28 November 2023, the expert panel reviewed the Phase III clinical study protocol presented by AstraZeneca for Baxdrostat Tablets.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm with the condition that
1. At least 50% of trial sites should be govt. sites & At least 50% subjects shall be enrolled from govt. sites.
2. Investigators in the study should be Cardiologists only.
3. Co-medication and Other treatment including follow up should be borne by the sponsor.
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