50% of trial sites should be Govt sites, more subjects should be enrolled from Govt sites: CDSCO panel tells AstraZeneca on Baxdrostat study
New Delhi: In line with the drug major AstraZeneca's protocol amendment proposal to study the cardiovascular drug Baxdrostat, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended for amendment as per the condition that at least 50% trial sites should be Govt. sites and more subjects shall be enrolled from Govt. sites.
Furthermore, the expert panel stated investigators in the study should be cardiologists only, and the standard of care along with study medication should be borne by the sponsor.
This came after the firm presented for waiver of condition (i and iii) and notification for acceptance of condition (ii), of clinical trial for protocol No. D6970C00002.
This is a randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of baxdrostat on the reduction of systolic blood pressure in participants with uncontrolled hypertension on two or more medications including participants with resistant hypertension.
Baxdrostat is an investigational drug that is being evaluated for the treatment of hypertension. It is an aldosterone synthase inhibitor.
Baxdrostat works by preventing the body from making aldosterone, a hormone that regulates the amount of salt in the body. Baxdrostat suppressed blood and urine levels of aldosterone
At the recent SEC meeting for Cardiovascular held on 9th July 2024, the expert panel reviewed the waiver of condition (i and iii) and notification for acceptance of condition (ii), of CT for protocol No. D6970C00002 presented by the drug major AstraZeneca.
After detailed deliberation, the committee recommended an amendment as per the conditions below:-
(i) At least 50% of trial sites should be Govt. sites and more subjects shall be enrolled from Govt. sites
(ii) Investigators in the study should be cardiologists only.
(iii) Standard of care along with study medication should be borne by the sponsor.
