Trial Profile
A multicenter, multinational, prospective observational post-authorization safety study of loxapine [Adasuve] in patients with agitation
Status:
Recruiting
Phase of Trial:
Phase IV
Latest Information Update: 19 Jun 2015
Price :
$35
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At a glance
- Drugs Loxapine (Primary)
- Indications Agitation
- Focus Adverse reactions
- Acronyms PASS
- Sponsors Alexza Pharmaceuticals
- 18 Jun 2015 According to a media release, Alexza Pharmaceuticals plans to transfer the EU Marketing authorization for ADASUVE (MAA) to Ferrer. The MAA transfer includes the responsibilities for the ongoing post-approval clinical studies (the PASS and DUS studies), a planned phase III trial in adolescents [see CT profile 700257964] and ongoing pharmacovigilance responsibilities.
- 14 Oct 2014 New trial record