NCT04179487 - 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)

Gillespie C, Foley S, Rowan M, Ewins K, NiAinle F, MacMahon P
The OPTICA study (Optimised Computed Tomography Pulmonary Angiography in Pregnancy Quality and Safety study): Rationale and design of a prospective trial assessing the quality and safety of an optimised CTPA protocol in pregnancy. Thromb Res. 2019 May;177:172-179. doi: 10.1016/j.thromres.2019.03.007. Epub 2019 Mar 13.

The OPTICA Study - A Prospective Study Assessing the Quality and Safety of an Optimised CTPA Protocol in Pregnancy

Clinical trial NCT04179487 - References