NCT01563445 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Diringer MN, Skolnick BE, Mayer SA, Steiner T, Davis SM, Brun NC, Broderick JP
Risk of thromboembolic events in controlled trials of rFVIIa in spontaneous intracerebral hemorrhage. Stroke. 2008 Mar;39(3):850-6. doi: 10.1161/STROKEAHA.107.493601.
Mayer SA, Brun NC, Broderick J, Davis SM, Diringer MN, Skolnick BE, Steiner T; United States NovoSeven ICH Trial Investigators
. Recombinant activated factor VII for acute intracerebral hemorrhage: US phase IIA trial. Neurocrit Care. 2006;4(3):206-14.
Mayer SA, Brun NC, Broderick J, Diringer MN, Davis SM, Steiner T
Safety and Preliminary Efficacy of Recombinant Coagulation Factor VII in Patients with Acute Intracerebral Hemorrhage. Stroke 2004; 35: 322

Multi-center, Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of Activated Recombinant Factor VII (NovoSeven®) for Preventing Early Hematoma Growth in Acute Intracerebral Hemorrhage (ICH)

Details for clinical trial NCT01563445

Clinical trial NCT01563445 - References