The first trial will study alternatives to transfemoral approaches in 1, 000 patients considered ineligible for aortic valve surgery.
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Following this initial safety trial a broader study across three European countries is planned.
The panel's decision was based almost entirely on the Jupiter trial, a study funded by Crestor's maker, AstraZeneca, that compared a daily dose of Crestor to placebo in nearly 18, 000 people who fit the description used by the panel (and who would not be eligible for a statin under the current guidelines).
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Drug companies would normally advance to a second trial before mounting a study that could lead to approval.
Jude trial and believes the study supports the PFO-closure theory.
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Patients with a particular type of lung cancer, called squamous cell carcinoma, were excluded from the trial because a previous study had found that they were more likely than other patients to experience bleeding of the lungs with Avastin therapy.
The content of his proposed topics is expected to be covered by other speakers as agency staff plan to summarize the available data on the cardiovascular safety of rosiglitazone at the committee meeting, and multiple FDA speakers will address their review of the readjudication of RECORD trial based on the study reports submitted to the Agency.
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Despite some limitations of trial design, including the open label nature of the study, RECORD remains the only randomized trial of cardiovascular outcomes for Avandia at this time.
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The trial was originally expected to study 11, 000 patients, but it was expanded last year.
Over the next day and a half, the idea of the screening trial combined with a larger study that comes later gathered steam.
According to the 2010 RBC Capital Markets study, when trial victories, settlements between drugmakers and dropped cases are combined, generic companies were able to bring their product to market before the brand-name drug's patent expired in 76 percent of the 371 drug patent suits decided from 2000 through 2009.
Matt Herper: Speeding forward a decade: Why did you decide to file for approval, FDA approval, that first time, given that the studies had missed their primary endpoints and that a third study, the IMPACT trial, was already going on?
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The latest study, a randomized trial of 80 women and men published in Plos One by Harvard researchers, shows that even when clinicians told women with irritable bowel syndrome they are getting fake pills, the fake pills still worked.
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But Merck is doing that big Vytorin versus Zocor study, a giant clinical trial called IMPROVE-IT.
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The RECORD study is the largest clinical trial designed to evaluate the cardiovascular safety of Avandia.
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The trial, by the way, will study one of three oral doses of the compound, called MK-8931, which will be administered daily versus a placebo.
And even if a natural-history study leads to a clinical trial for a treatment, there is no guarantee the same children will be allowed to participate.
Carlson is running a study called the Experience Corps Trial, in which older men and women volunteer to teach reading skills to kindergarten through third graders in Baltimore city schools.
If a therapy eventually is developed, and a clinical trial begins, a natural-history study can be used to help evaluate whether it is working to slow or stop the disease.
The large size of the trial has led to concerns that the study will never collect enough events, or that it could drag on for years until after Zetia's patent expires in 2016.
Researchers don't yet know how to explain these correlations -- and since the study was not a controlled trial, it's not clear whether marijuana or some other factor in marijuana users' lifestyles actually accounted for the beneficial effects.
The New York-based drug giant says last night it received news that in a study, sponsored by the National Cancer Institute, on using Celebrex to prevent cancerous colon polyps, the drug more than doubled the risk of heart attacks and strokes. (The risk showed up with the highest dose of Celebrex.) That study, called the APC trial, has been halted.
An ongoing UK study, The Warwick Microwind Trial Project appears to cast further doubt over the usefulness of turbines in urban environments.
In December of 2001, Merck seemed to indicate it would mount such a study--but the clinical trial never seems to have materialized, even though the firm started a similar trial for Arcoxia, a successor drug to Vioxx.
But Pfizer says that a second, similar study--called the PreSAP trial--does not show an increase in cardiovascular events, and that it still hopes to go forward with a study to prevent heart attacks in patients with osteoarthritis.
Because the Framingham Heart Study is not a randomized controlled trial, it's still not clear if vitamin D is the real reason for the link (the vitamin's levels could drop in unhealthy people for other reasons), or if taking a supplement would lower the risk.
Significantly more patients in the niacin arm stopped their study treatment during the course of the trial (25.4% versus 16.6%).
Instead, a letter has been sent to the ENHANCE study's lead investigator saying the trial would be part of the "invited presentations" program.
One study, known as the Four Areas Trial, found reductions in cattle TB incidence ranging from 51% to 68% over a five-year culling period.
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