WHO ICTRP trial
A Clinical Study to Test the Effectiveness and Side Effects of…
CTRI/2021/06/034322 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2021/06/034322 |
|---|---|
| Public title | A Clinical Study to Test the Effectiveness and Side Effects of Hetero-Tenecteplase in Adult patients with Suspected Myocardial Infarction |
| Scientific title | A Prospective, Multicenter, Randomized, Comparative, Parallel Group Clinical Study to Compare The Efficacy, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Intravenous Injection of Tenecteplase (Hetero Biopharma Limited) and Reference Medicinal Product (RMP-Tenecteplase, Boehringer… |
| Primary sponsor | Hetero Biopharma Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | India |
| Conditions | Health Condition 1: I213- ST elevation (STEMI) myocardial infarction of unspecified site |
| Interventions | Intervention1: Hetero-Tenecteplase: Single dose of Hetero-Tenecteplase on the basis of body weight, with a maximum dose of 10,000 units (50 mg tenecteplase). Tenecteplase is for intravenous administration only. Control Intervention1… |
| Registration date | Jun 21, 2021 |
| Target size | 198 |
| Secondary IDs | HCR/III/TENESTEMI/08/2020; Version 1.0 Dated 05-08-2020 |
| Registry page | ctri.nic.in |
At a glance
- No Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: