This follows a previous announcement earlier in the month that the first pivotal Phase III trial
, GALATHEA, also failed to meet its primary endpoint.
The investigational drug dimebon failed to show any benefit over placebo for patients with mild to moderate Alzheimer's disease on any of the efficacy end points in a 6-month, phase III trial
, drug manufacturers Medivation Inc.
A company or investigator may choose to perform Phase IV studies to investigate the effects of different doses or dosing schedules from those used in Phase II and Phase III trials
; to determine the behavior of the drug in different patient populations or in patients with earlier or more advanced stages of disease; to monitor long-term effectiveness of the new agent; to compare the drug with other drugs available on the market; or to compare the cost effectiveness of the drug with that of other products.
In addition to the two successful pivotal Phase III trials
needed before an NDA can be filed, numerous additional special trials are usually demanded by regulatory agencies throughout the course of the IND clinical development period encompassing Phases I through III.
The 2 Phase III trials
will enroll 600 patients, the company says.
(37) In accordance with WHO and FDA recommendations, carcinogenicity studies in animals will be completed before additional phase III trials
announced that the Independent Data Monitoring Committee, or IDMC, for the ongoing inclisiran Phase III trials
has recommended that the trials continue as designed and conducted, without modification.
The pivotal phase III trials
GALATHEA and TERRANOVA are randomised, double -blinded, 56-week placebo-controlled, multi-centre trials assessing the safety and efficacy of Fasenra as an add-on to dual or triple inhaled therapy compared to placebo in patients with moderate to very severe COPD with a history of exacerbations across a range of baseline blood eosinophils.
The initiation of the Japanese study means that the Pan-European and Japanese Phase III trials
combined aim to treat maximum 420 moderate to severe ARDS patients with results expected to become available in 2017-2018.
8 November 2011 - Anglo-Swedish pharma major AstraZeneca plc (LON:AZN, STO:AZN) and its US partner Targacept Inc (NASDAQ:TRGT) said today their joint project, experimental antidepressant TC-5214, failed to reach the primary endpoint in the first of four Phase III trials
DSP expects the addition of irbesartan, which is currently under phase III trials
in Japan, to further expand its line up of anti-hypertension drug.
Alexion's two lead product candidates, pexelizumab and eculizumab, are currently undergoing evaluation in several clinical development programs, including two Phase III trials
of eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a Phase III trial
of pexelizumab in coronary artery bypass graft (CABG) surgery patients undergoing cardiopulmonary bypass (trial completed), and a Phase III trial
of pexelizumab in acute myocardial infarction (AMI) patients.