Clinical investigation on medicinal products in the treatment of hypertension

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Current effective version

Revision 4 - Adopted guideline

Reference numberEMA/CHMP/29947/2013/Rev. 4
Published08/07/2016
Effective from01/01/2017
KeywordsHypertension, clinical evaluation, fixed dose combination, first line therapy, substitution therapy, efficacy criteria, safety aspects
DescriptionThis document provides guidance on the design of clinical studies for the evaluation of antihypertensive drugs. It adresses the regulatory rquirements for different indications of fixed dose combinations in the treatment of hypertension.


Document history

Revision 4

Current version

Adopted guideline

 

Overview of comment

 

Draft guideline


Concept paper

Published: 08/07/2016

 

Published: 08/07/2016

 

Published: 31/07/2013


Published: 23/07/2009

Revision 3

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/12/2011-31/12/2016


Published: 21/12/2010


Published: 22/01/2009


Published: 18/10/2006

Revision 2 Adopted guidelineIn operation: 01/12/2004-30/11/2011
Revision 1Adopted guidelineIn operation: 01/11/1997-30/11/2004


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