phase 3 clinical trial


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phase 3 clinical trial

Phase 3 study. See Phase study.
References in periodicals archive ?
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.
The product has been Fast Tracked by the FDA and the Company has commenced a Phase 3 clinical trial.
This Phase 3 clinical trial was a randomized, double-blind, placebo-controlled, multi-center, parallel group trial designed to assess the efficacy and safety of 1mg and 3mg of SILENOR[TM] in elderly patients with chronic primary insomnia.
CancerVax has been evaluating Canvaxin(TM) in a Phase 3 clinical trial for the treatment of patients with Stage III melanoma in collaboration with Serono.
The phase 3 clinical trial was a double-blind, randomized, placebo-controlled study that enrolled AMI patients with opioid-induced constipation.
The completion of enrollment in this Phase 3 clinical trial is an important milestone in our efforts to complete the clinical development of, seek regulatory approval for and, if we are successful, make Canvaxin(TM) available to treat patients with this deadly disease," said David F.
CancerVax has built a portfolio of novel oncology therapies and platforms, including our product candidate, Canvaxin(TM), which is in international Phase 3 clinical trials for the treatment of patients with Stage III or Stage IV, or advanced-stage, melanoma.
The DSMB also recommended the continuation of CancerVax's other Phase 3 clinical trial of Canvaxin(TM) for the treatment of patients with Stage IV melanoma.
Following such production, the Company will need to demonstrate that batches can be produced aseptically and that the batches have similar properties as batches of AI-700 being used in the Phase 3 clinical trials and then submit this data to the FDA.
Valeant also announced that it has appointed Quintiles Transnational as its clinical research organization partner for the Phase 3 clinical trials.
We are currently conducting two pivotal, Phase 3 clinical trials to evaluate our product candidate, Canvaxin(TM), for the treatment of Stage III and Stage IV melanoma at 80 clinical trial sites throughout the world.
Progenics has ongoing clinical programs for MNTX with three dosage forms: Subcutaneous MNTX is the subject of two, pivotal phase 3 clinical trials in opioid-induced constipation in patients with advanced medical illness; intravenous MNTX is being studied in a phase 2 trial for treatment of post-operative ileus; and oral MNTX is being developed for relief of opioid-induced constipation in patients with chronic pain.