Paediatric addendum to the guideline on clinical investigation on medicinal products in the treatment of hypertension - Scientific guideline

This document is an addendum to the guideline on clinical investigation of medicinal products in the treatment of hypertension. It highlights differences from adult patients with arterial hypertension and points out paediatric-specific aspects.

Keywords: Paediatric, drug evaluation, drug approval guideline, hypertension, clinical evaluation, efficacy criteria, safety aspects

Current effective version

Paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension

AdoptedReference Number: EMA/CHMP/206815/2013Summary:

This is an addendum to the Guideline on Clinical Investigation of Medicinal Products in the Treatment of Hypertension (EMA/238/1995/Rev. 3, 18 November 2010). It is not meant as a guidance document on its own but rather highlights differences from adult patients with arterial hypertension and points out paediatric-specific aspects.

Document history - First version (current)

Paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension

AdoptedReference Number: EMA/CHMP/206815/2013Summary:

This is an addendum to the Guideline on Clinical Investigation of Medicinal Products in the Treatment of Hypertension (EMA/238/1995/Rev. 3, 18 November 2010). It is not meant as a guidance document on its own but rather highlights differences from adult patients with arterial hypertension and points out paediatric-specific aspects.

Overview of comments received on 'Paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension'

Reference Number: EMA/CHMP/68390/2015

Draft paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension

Consultation dates: 30/09/2013 to 31/03/2014Draft: consultation closedReference Number: EMA/CHMP/206815/2013Summary:

This is an addendum to the guideline on clinical investigation of medicinal products in the treatment of hypertension (EMA/238/1995/Rev. 3, 18 November 2010). It is not meant as a guidance document on its own but rather highlights differences from adult patients with arterial hypertension and points out paediatric-specific aspects.

Concept paper on the need for the development of a paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension

Reference Number: EMEA/CHMP/EWP/545456/2008