NCT01311791 - 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)

Anker SD, Coats AJ, Cristian G, Dragomir D, Pusineri E, Piredda M, Bettari L, Dowling R, Volterrani M, Kirwan BA, Filippatos G, Mas JL, Danchin N, Solomon SD, Lee RJ, Ahmann F, Hinson A, Sabbah HN, Mann DL
A prospective comparison of alginate-hydrogel wi
Mann DL, Lee RJ, Coats AJ, Neagoe G, Dragomir D, Pusineri E, Piredda M, Bettari L, Kirwan BA, Dowling R, Volterrani M, Solomon SD, Sabbah HN, Hinson A, Anker SD
One-year follow-up results from AUGMENT-HF: a multicentre randomized controlled clinical tria

A Randomized, Controlled Study to Evaluate the Safety and Cardiovascular Effects of Algisyl-LVR™ as a Method of Left Ventricular Augmentation in Patients With Dilated Cardiomyopathy (AUGMENT-HF)

Details for clinical trial NCT01311791

Clinical trial NCT01311791 - References