CLEAR Outcome Study definition

CLEAR Outcome Study means the Clinical Study (1002-043 study) conducted by or on behalf of Esperion pursuant to the protocol entitled “A Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of Bempedoic Acid (ETC-1002) on the Occurrence of Major Cardiovascular Events in Patients with, or at high risk for, Cardiovascular Disease who are Statin Intolerant”.
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CLEAR Outcome Study means CLEAR (“Cholesterol Lowering via Bempedoic Acid, an ACL-inhibiting Regimen”) outcome study, NCT number: NCT02993406.
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Examples of CLEAR Outcome Study in a sentence

  • Esperion agrees to provide DSE any necessary support or information (in Esperion’s possession and control) to allow DSE to communicate effectively with EMA regarding such pending applications, including without limitation any such information relating to the CLEAR Outcome Study.

Related to CLEAR Outcome Study

  • Home study means the assessment process used for the purpose of determining the ability of an applicant to care for a child in need of foster care placement.

  • Treatability study means a study in which a hazardous waste is subjected to a treatment process to determine: (1) Whether the waste is amenable to the treatment process, (2) what pretreatment (if any) is required, (3) the optimal process conditions needed to achieve the desired treatment, (4) the efficiency of a treatment process for a specific waste or wastes, or (5) the characteristics and volumes of residuals from a particular treatment process. Also included in this definition for the purpose of the § 261.4 (e) and (f) exemptions are liner compatibility, corrosion, and other material compatibility studies and toxicological and health effects studies. A “treatability study” is not a means to commercially treat or dispose of hazardous waste.

  • 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.

  • Quarterly (1/Quarter) sampling frequency means the sampling shall be done in the months of March, June, August, and December, unless specifically identified otherwise in the Effluent Limitations and Monitoring Requirements table.

  • 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.