Clinical investigation on medicinal products in the treatment of hypertension
| Current effective version |
|
| Reference number | EMA/CHMP/29947/2013/Rev. 4 |
| Published | 08/07/2016 |
| Effective from | 01/01/2017 |
| Keywords | Hypertension, clinical evaluation, fixed dose combination, first line therapy, substitution therapy, efficacy criteria, safety aspects |
| Description | This 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 |
| Published: 08/07/2016
Published: 08/07/2016
Published: 31/07/2013 Published: 23/07/2009 |
| Revision 3 | In operation: 01/12/2011-31/12/2016 Published: 21/12/2010 Published: 22/01/2009 Published: 18/10/2006 | |
| Revision 2 |
 Adopted guideline
| In operation: 01/12/2004-30/11/2011 |
| Revision 1 |
Adopted guideline
| In operation: 01/11/1997-30/11/2004 |