MACE Plus Study definition

MACE Plus Study means the component of the CVOT relating to the co-primary objective of assessing whether or not treatment with the Initial Product reduces the incidence of major adverse cardiovascular events including in totality or in part the following events: stroke or myocardial infarction; cardiovascular death or hospitalization for unstable angina or heart failure; or any coronary revascularization compared to placebo (“MACE Plus”), but excluding any component relating to the CVOT required by the FDA to be conducted in connection with the approval of the Initial Product. For clarity, if a component relates to assessing whether or not treatment with the Initial Product reduces the incidence of MACE Plus and some other component of the CVOT, it shall not be considered part of the MACE Plus Study for purposes of this Agreement.
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Related to MACE Plus Study

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.