phase 3 clinical trial


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phase 3 clinical trial

Phase 3 study. See Phase study.
References in periodicals archive ?
The company may also consider applying for European orphan drug designation for XL119 following the commencement of the Phase 3 clinical trial in Europe.
The company said OneStep-1 and OneStep-2 are identical, pivotal Phase 3 clinical trials (180 patients per clinical trial) being conducted under a Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration for evaluation of Locilex for the treatment of patients with mild infections of diabetic foot ulcers.
Under the partnership, Pfizer dosed the first patient in the RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) study, which is a Phase 3 clinical trial assessing the efficacy and safety of rivipansel for treating vaso-occlusive crisis (VOC) in patients hospitalised with sickle cell disease who are six years of age or older.
Cerus and Baxter are submitting the results of the European Phase 3 clinical trial for presentation at the annual meeting of the American Society of Hematology in December 2000.
Biopharmaceutical company Intra-Cellular Therapies (NasdaqGS:ITCI) said on Monday that it has enrolled 450 adult patients under the first Phase 3 clinical trial (ITI-007-301) of its lead product candidate ITI-007 in patients with schizophrenia, a disabling and chronic mental illness affecting over 1% of the world's population.
Spero's planned pivotal Phase 3 clinical trial of SPR994, ADAPT-PO, is designed as a double-blind, double-dummy trial to compare oral SPR994 with an existing standard of care intravenous (IV) antibiotic, ertapenem, in approximately 1,200 patients randomized 1:1 in each arm.
The final data expand on the interim data announced in July, and the company anticipates the data will support the advancement of SPR994 at a dose of 600 mg administered three times per day into a pivotal Phase 3 clinical trial, which the company expects to initiate around year-end in patients with complicated urinary tract infections, or cUTI.
Higher research and development costs were driven primarily by a $5.3M increase in clinical trial costs related to the ongoing confirmatory Phase 3 clinical trial of Amphora for prevention of pregnancy and the ongoing Phase 2b clinical trial of Amphora for prevention of chlamydia and gonorrhea, both of which trials initiated in the second half of 2017, and a $2.3 million increase in non-cash stock-based compensation associated with options granted in the second quarter of 2018.
Based on review of the Phase 2 GENETIC-AF trial results, as well as its alignment with previous Phase 3 pharmacogenetic substudy data, the FDA stated that data from a single pivotal Phase 3 clinical trial may be sufficient to support approval of Gencaro for the treatment of AF in patients with HF.
The data demonstrate that SPR994 has a favorable safety, pharmacokinetic and pharmacodynamic profile that supports the advancement of SPR994 to a pivotal Phase 3 clinical trial at a 300 mg dose administered three times per day.
Galectin Therapeutics announced it is proceeding with plans for a Phase 3 clinical trial program with its galectin-3 inhibitor GR-MD-02 in NASH cirrhosis, incorporating advice and guidance obtained in a meeting with the FDA.
PROTECTOR 1 is the first of two global Phase 3 clinical trials evaluating the potential of RTB101 to improve the immune function of patients aged 65 and older and thereby decrease the incidence of illness associated with respiratory tract infections.