Clinical investigation on medicinal products in the treatment of hypertension - Scientific guideline

This document provides guidance on the design of clinical studies for the evaluation of antihypertensive drugs. It addressees the regulatory requirements for different indications of fixed dose combinations in the treatment of hypertension.

Keywords: Hypertension, clinical evaluation, fixed dose combination, first line therapy, substitution therapy, efficacy criteria, safety aspects

Current effective version

Guideline on clinical investigation of medicinal products in the treatment of hypertension - Revision 4

Adopted Reference Number: EMA/CHMP/29947/2013/Rev. 4 Legal effective date: 01/01/2017 Summary:

This is the 4th revision of the Guideline on clinical investigation of medicinal products in the treatment of hypertension.

Document history - Revision 4

Guideline on clinical investigation of medicinal products in the treatment of hypertension - Revision 4

Adopted Reference Number: EMA/CHMP/29947/2013/Rev. 4 Legal effective date: 01/01/2017 Summary:

This is the 4th revision of the Guideline on clinical investigation of medicinal products in the treatment of hypertension.

Overview of comments received on guideline on clinical investigation of medicinal products in the treatment of hypertension (EMA/CHMP/29947/2013/Rev.4)

Reference Number: EMA/CHMP/345847/2015

Draft guideline on clinical investigation of medicinal products in the treatment of hypertension - Revision 4

Draft: consultation closed Consultation dates: 31/07/2013 to 31/01/2014 Reference Number: EMA/CHMP/29947/2013/Rev. 4 Summary:

This is the fouth revision of the guideline on clinical investigation of medicinal products in the treatment of hypertension. The main aim of this revision is to include more comprehensive guidance on the collection of long-term safety data and to clarify the situations in which outcome studies might be required in order to detect potential long-term effects on mortality and morbidity.

Concept paper on the need to update the note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders and the note for guidance on the clinical investigation on hypertension - Revision 4

Reference Number: EMEA/CHMP/EWP/350495/2009

Document history - Revision 3

Guideline on clinical investigation of medicinal products in the treatment of hypertension

Adopted Reference Number: EMA/238/1995/Rev. 3

Overview of comments received on draft guideline on clinical investigation of medicinal products in the treatment of hypertension

Reference Number: EMA/CHMP/EWP/599934/2009

Draft guideline on clinical investigation of medicinal products in the treatment of hypertension

Draft: consultation closed Reference Number: CPMP/EWP/238/95 Rev. 3

Draft concept paper on the revision of the guidance on fixed combination medicinal products in the treatment of hypertension

Draft: consultation closed Reference Number: CHMP/EWP/426093/2006

Document history - Revision 2

Note for guidance on clinical investigation of medicinal products in the treatment of hypertension

Adopted Reference Number: CPMP/EWP/238/95 Rev. 2 Legal effective date: 01/12/2004

Document history - Revision 1

Clinical investigation on medicinal products in the treatment of hypertension (Rev.1)

Adopted Reference Number: CPMP/EWP/238/95 Rev. 1