Clinical investigation on medicinal products in the treatment of hypertension

  • Email
  • Help
Current effective version

Revision 4 - Adopted guideline

Reference numberEMA/CHMP/29947/2013/Rev. 4
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

Related content

How helpful is this page?

Average rating:

 Based on 25 ratings

Add your rating:

See all ratings
5 ratings
5 ratings
5 ratings
5 ratings
5 ratings

Tell us more