- Trials with a EudraCT protocol (115)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (8)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Abropernol (tablets) [AWB-AT] |
Active substance: Abropernol - Tabletten |
Study summary document link (including results): |
View full study record |
Document reference: 39760 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Abropernol (tablets) [AWB-AT] |
Active substance: Abropernol N |
Study summary document link (including results): |
View full study record |
Document reference: 39762 |
Study title: Clinical Study on the Efficacy and Tolerability of Acarbose (BAY g 5421) Compared with Placeboin Diabetic Children on Conventional Insulin Treatment, in Particular with Observation of the Glycemic Control Index ( PH-24820 ) |
Active substance: ACARBOSE |
Study summary document link (including results): Bayer Pharma_Acarbose_0665_study_synopsis.pdf |
View full study record |
Document reference: 46158 |
Study title: Guillet J, Blanquet P, Guillet G, Mollard S, Massicot P, Maleville J. The use of technetium Tc 99m medronate scintigraphy as a prognostic guide in childhood dermatomyositis. Arch Dermatol. 1981 Aug;117(8):451. No abstract available. Guillet J, Blanquet P, Guillet G, Mollard S, Massicot P, Maleville J. The use of technetium Tc 99m medronate scintigraphy as a prognostic guide in childhood dermatomyositis. Arch Dermatol. 1981 Aug;117(8):451. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44115 |
Study title: Blockers and hypoglycaemia (assesment of cadioselective and intrinsic sympathometic properties in relation to severity of hypoglycaemia - No author - 1984 (Current Therapeutic Research 36, n° 2, p. 361-373) ; - Publication in Documentation clinique du dossier d'AMM du 30/10/1987 - |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46182 |
Study title: Clinical and echocardiographic (echo) long-term follow-up of children with severe hypertension (HT) - Loirat C. et al. - No date (Hopital Bretonneau, INSERM U 120, Paris) ; - Publication in Documentation clinique du dossier d'AMM du 30/10/1987 - |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46183 |
Study title: Clinical pharmacology and therapeutic utilization of anti-hypertensive agents in children - Mirkin B.L., Sinaiko - 1977 In : (New M.I., Levine L.S. Juvenile hypertension, pp. 195-218. New-York, Raven Press.) - Publication in expertise clinique pour le dossier français de demande d'extension des indications thérapeutiques de Sectral 200mg comprimés, au traitement de l'hypertension artérielle de l'enfant - Pr Broyer - 14/06/1983 - |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46184 |
Study title: Experience with acebutolol in the treatment of juvenile hypertension - J. Liška et al.- 2005 (VOX PEDIATRIAE – January 2005 – No.1 – Volume 5) |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46185 |
Study title: Expertise clinique pour le dossier français de demande d'extension des indications thérapeutiques de Sectral 200 mg comprimés, au traitement de l'hypertension artérielle de l'enfant - Pr Broyer - 14/06/1983 |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46186 |
Study title: La tension artérielle chez l'enfant et l'adolescent. Valeurs rapportées à l'âge et à la taille chez 17.067 sujets - André J.L., Deschamps J.P., Gueguen R. - 1980 (Arch. Franç., 37, 1477) ; - Publication in expertise clinique pour le dossier français de demande d'extension des indications thérapeutiques de Sectral 200 mg comprimés, au traitement de l'hypertension artérielle de l'enfant - Pr Broyer - 14/06/1983 - |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46187 |
Study title: Nouveaux regards sur l'hypertension artérielle de l'enfant - Broyer M., André J.L. - 1980 (Arch. Franç. Pediatr., 37, pp. 429-432) ; - Publication in expertise clinique pour le dossier français de demande d'extension des indications thérapeutiques de Sectral 200 mg comprimés, au traitement de l'hypertension artérielle de l'enfant - Pr Broyer - 14/06/1983 - |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46188 |
Study title: Propanolol as an antihypertensive agent in children - Griswold W.R., Moneal R., Mendoza S.A. et al. - 1978 (Arch. Dis. Child. 537. pp 594-596) - Publication in Expertise clinique pour le dossier français de demande d'extension des indications thérapeutiques de Sectral 200 mg comprimés, au traitement de l'hypertension artérielle de l'enfant - Pr Broyer - 14/06/1983 - |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46189 |
Study title: Relazione sulla sperimentazione clinica del Sectral Roger Bellon nelle aritmie - Centro A De Gasperis Milano - Prof F Rovelli - 03 Jan 1978 |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46190 |
Study title: Report of the task force on blood pressure control in children - Blumenthal S., Epps R.P., Heavenrich R., Laver R.M., Lieberman E. and al. - 1977 (Pediatrics, suppl., 59, 797) ; - Publication in expertise clinique pour le dossier français de demande d'extension des indications thérapeutiques de Sectral 200 mg comprimés, au traitement de l'hypertension artérielle de l'enfant - Pr Broyer - 14/06/1983 - |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46191 |
Study title: Résultats du traitement de l'hypertension artérielle essentielle après administration prolongée (24 mois) d'acebutolol - Fillastre J.P., Letac B., Wolf L.M.- 1975 (Nouv. Presse Med. 4, pp. 3282-3286) ; - Publication in expertise clinique pour le dossier français de demande d'extension des indications thérapeutiques de Sectral 200 mg comprimés, au traitement de l'hypertension artérielle de l'enfant - Pr Broyer - 14/06/1983 - |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46192 |
Study title: Spectral enfant – solution buvable à 40mg/ml – renseignements particuliers – partie V - No author - 01/10/1987 |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46193 |
Study title: Tolérance de 5 jours par voie orale chez le raton et le rat adulte suivie d’une période sans traitement de 15 jours (documentation toxicologique du dossier d’AMM du 30/10/87 du spectral enfant solution buvable 40mg/ml) - Briffaux - 02/10/1987 |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46194 |
Study title: Utilisation de l'acébutolol dans le traitement de l'hypertension artérielle de l'enfant et de l'adolescent - Andre J.L. & Spyckerelle - 1982 (Gazette médicale de France 89, n° 20, p. 2452-2454) ; - Publication in Documentation clinique du dossier d'AMM du 30/10/1987 - |
Active substance: ACEBUTOLOL |
Study summary document link (including results): |
View full study record |
Document reference: 46195 |
Study title: Solcoderm study 006-I2: "A double-blind evaluation of Solcoderm variants using pairs of comparable skin tumors." |
Active substance: ACETIC ACID_OXALIC ACID_NITRIC ACID_LACTIC ACID_COPPER (II) NITRATE |
Study summary document link (including results): |
View full study record |
Document reference: 21249 |
Study title: Etude de l'absorption de l' "aspégic enfants nourissons" selon les modalités d'administration par voie orale - C. Dubray, A. Labbe, EJ Raynaud, M. Paire, J. Lavarenne - 1983 - Publication in the report N° FILIRF-FRZ0069-EN-E01 - |
Active substance: ACETYL SALICYLIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 46172 |