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The trial enrolled only participants who had at least two attacks during the eight-week period. [4] Participants were assigned to receive one of two doses of berotralstat or placebo once every day for 24 weeks. [4] Neither the participants nor the investigators knew which treatment was being given until after the trial was completed. [4]
Avapritinib, sold under the brand name Ayvakit among others, is a medication used for the treatment of advanced systemic mastocytosis and indolent systemic mastocytosis. It is also used for the treatment of tumors due to one specific rare mutation: it is specifically intended for adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) that harbor a platelet-derived growth ...
The trial was conducted at 46 sites in 10 countries (Australia, Austria, Belgium, Canada, France, Germany, Japan, Korea, Switzerland, and the United States). [17] The US Food and Drug Administration (FDA) granted the application for sotorasib orphan drug, fast track, priority review, and breakthrough therapy designations.
Romosozumab is used for osteoporosis to decrease the risk of fractures. [10] Two trials found that it reduced the rate of vertebral fracture. In one, there was a 73% lower risk of vertebral fracture after one year, and the benefit was maintained after a second year of taking denosumab.
The trial was conducted at 53 sites in the United States, South Korea, Taiwan, Japan, Great Britain, France, Spain, Canada, China, and Australia. [ 15 ] The FDA collaborated on the review of amivantamab with the Brazilian Health Regulatory Agency (ANVISA) and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA). [ 6 ]
The trial's primary endpoint was the proportion of subjects who were infected with influenza virus and presented with fever and at least one respiratory symptom from day 1 to day 10. [12] Of those who received baloxavir marboxil, 1% of subjects met these criteria, compared to 13% of subjects who received a placebo for the clinical trial.
The US Food and Drug Administration (FDA) approved crizanlizumab based on evidence from one clinical trial (Trial 1/NCT01895361) of 132 participants with sickle cell diseases who had a history of vaso-occlusive crisis. [8] The trial was conducted at 60 sites in the United States, Brazil and Jamaica. [8]
In trial 1, participants received either avalglucosidase alfa or another drug (called the active comparator) intravenously once every two weeks for 49 weeks. [9] Neither the participants nor the healthcare providers knew which treatment was being given until after week 49. [9] Participants in this trial were followed for up to five years. [9]
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