E12: Principles for Clinical Evaluation of New Antihypertensive Drugs Consensus Draft Principle

Regulatory Resource: E12: Principles for Clinical Evaluation of New Antihypertensive Drugs Consensus Draft Principle

Description:

This therapeutic area guideline considers the Clinical Evaluation of New Antihypertensive Drugs. It provides a set of "Principles" on which there is general agreement among all three ICH regions covering endpoints and trial designs. Since there are a few differences in the requirements of the three regions that have not been harmonised, this document should be considered an "ICH Principle Document" rather than an "ICH Guideline". It will not be subject to the usual procedures leading to a fully harmonized document.

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