phase III trial

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phase III trial

, phase 3 trial
A clinical trial to explore the clinical use of a new drug, esp. relative to other known effective agents (the current standard of care). These trials often include thousands of enrollee patients. By law, all such patients receive real treatment; no placebos are given. But the trial is usually double-blinded, with patients divided randomly into two groups: an experimental group and a control group on standard treatment, with neither patients nor researchers knowing to which group the patient belongs.
See also: trial
References in periodicals archive ?
Based on the written minutes from the End-of-Phase 1 meeting, PhaseBio believes that it has reached general agreement with the FDA on the overall design of a single, non-randomized, open label Phase 3 trial of major bleeding and urgent surgical populations to support the submission of a Biologics License Application ('BLA') for potential accelerated approval of PB2452.
Zealand Pharma A/S (Zealand) (Nasdaq: ZEAL), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced on Tuesday successful results in the confirmatory phase 3 trial with dasiglucagon for severe hypoglycaemia in diabetes.
Consequently, the company says it is confident that the total number of randomized patients enrolled in the Phase 3 trial is sufficient to show whether Revascor is superior to placebo in the trial's primary endpoint of reduction in heart failure related hospital admissions, and in the key secondary endpoint of reduction in cardiac deaths.
In April 2017, the Phase 3 trial was successful in a pre-specified futility analysis of the primary efficacy endpoint in the first 270 patients.
Spherix President and CEO Richard Levin said, "The signing of Anaclim completes the team we need to carry out the whole Phase 3 trial. If the trial is successful, Spherix will submit a new drug application to the FDA.
The Phase 3 trial is evaluating whether Revascor reduces recurrent non-fatal heart failure-related major adverse cardiac events (HF-MACE), and prevents or delays terminal cardiac events (TCEs), defined as cardiovascular death, heart transplant or placement of an artificial device, over at least 12 months.
The phase 3 trial, called ECLIPSE, enrolled 1,048 patients to assess the efficacy and safety of Tremfya in comparison to Cosentyx.
M2 PHARMA-December 14, 2018-Janssen Pharmaceutical's psoriasis drug achieves primary endpoint in phase 3 trial
Global Banking News-September 28, 2018-Zealand Pharma initiates paediatric phase 3 trial with dasiglucagon for treatment of severe hypoglycaemia in children
Minerva has five late-stage clinical efficacy trials ongoing with three product candidates, including a Phase 3 trial with roluperidone for negative symptoms in patients with schizophrenia, a Phase 2b trial with MIN-117 for major depressive disorder associated with anxiety and three Phase 2b trials with seltorexant for insomnia disorder and MDD.
M2 EQUITYBITES-September 28, 2018-Zealand Pharma initiates paediatric phase 3 trial with dasiglucagon for treatment of severe hypoglycaemia in children
M2 PHARMA-September 28, 2018-Zealand Pharma initiates paediatric phase 3 trial with dasiglucagon for treatment of severe hypoglycaemia in children