Clinical investigation on medicinal products in the treatment of hypertension

Current effective version

PDF iconRevision 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

PDF iconAdopted guideline

PDF iconOverview of comment

PDF iconDraft guideline


PDF iconConcept paper

Published: 08/07/2016

Published: 08/07/2016

Published: 31/07/2013


Published: 23/07/2009

Revision 3

PDF iconAdopted guideline


PDF iconOverview of comments


Draft guideline


PDF iconConcept paper

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


Published: 21/12/2010


Published: 22/01/2009


Published: 18/10/2006

Revision 2 PDF iconAdopted guideline In operation: 01/12/2004-30/11/2011
Revision 1 PDF iconAdopted guideline In operation: 01/11/1997-30/11/2004


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