- Trials with a EudraCT protocol (356)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (35)

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: Presynaptic catecholamine antagonists as treatment for Tourette syndrome. Effects of alpha methyl para tyrosine and tetrabenazine. |
Active substance: BENZATROPINE |
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Document reference: 22252 |
Study title: Presynaptic catecholamine antagonists as treatment for Tourette syndrome. Effects of alpha methyl para tyrosine and tetrabenazine. |
Active substance: BENZATROPINE |
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Document reference: 41956 |
Study title: Six Week, Double-Blind, Safety Study of Beclomethasone Dipropionate Oral Aerosol vs. Placebo in Children (Less than 6 Years of Age) with a Clinical Diagnosis of Asthma or History/Active Wheezing and/or Usage of Beta-Agonists Compatible with the Diagnosis of Asthma |
Active substance: BECLAMETHASONE |
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Document reference: 22239 |
Study title: A randomised, double-blind, double-dummy, parallel-group, multicentre, phase-III study to investigate the effect of Symbicort® Turbuhaler® (budesonide/formoterol) 1280/36 µg total delivered dose in the treatment of acute asthma compared with Oxis® Turbuhaler® (formoterol) 36 µg total delivered dose in adolescent and adult patients not responding adequately to β2-agonists |
Active substance: BUDESONIDE AND FORMOTEROL |
Study summary document link (including results): D5896C00005 CSR Synopsis.pdf |
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Document reference: 23043 |
Study title: Meier CM et al 2007 British Journal of Clinical Pharmacology 2007;63(5):628. Palatability of angiotensin II antagonists among nephropathic children.Meier CM et al 2007 British Journal of Clinical Pharmacology 2007;63(5):628. Palatability of angiotensin II antagonists among nephropathic children. |
Active substance: CANDESARTAN CILETEXIL |
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Document reference: 23217 |
Study title: Meier CM et al. Palatability of angiotensin II antagonists among nephropathic children. British Journal of Clinical Pharmacology 2007;63(5):628.Meier CM et al. Palatability of angiotensin II antagonists among nephropathic children. British Journal of Clinical Pharmacology 2007;63(5):628. |
Active substance: CANDESARTAN CILETEXIL |
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Document reference: 23213 |
Study title: Palatability of angiotensin II antagonists among nephropathic children. Meier CM 2007Palatability of angiotensin II antagonists among nephropathic children. Meier CM 2007 |
Active substance: CANDESARTAN CILETEXIL |
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Document reference: 23204 |
Study title: Esperienza clinica con alpha−bloccanti e calcioantagonisti nel trattamento perioperatorio del feocromocitoma. (Clinical experience with alpha blockers and calcium antagonists in the perioperative treatment of pheochromocytoma). Furino A, Massagli C, Pesce CV, Vulpis V. Minerva anestesiologica, { Dec 1994, vol. 60, no. 12, p. 719−23Esperienza clinica con alpha−bloccanti e calcioantagonisti nel trattamento perioperatorio del feocromocitoma. (Clinical experience with alpha blockers and calcium antagonists in the perioperative treatment of pheochromocytoma). Furino A, Massagli C, Pesce CV, Vulpis V. Minerva anestesiologica, { Dec 1994, vol. 60, no. 12, p. 719−23 |
Active substance: DILTIAZEM |
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Document reference: 26133 |
Study title: Beta−adrenoblokatory i antagonisti kal'tsiia pri gipertroficheskoi kardiomiopatii. (Beta−adrenergic blockers and calcium antagonists in hypertrophic cardiomyopathy).Korovina EP. Klinicheskaia meditsina, 1998, vol. 76, no. 12, p. 30−5Beta−adrenoblokatory i antagonisti kal'tsiia pri gipertroficheskoi kardiomiopatii. (Beta−adrenergic blockers and calcium antagonists in hypertrophic cardiomyopathy).Korovina EP. Klinicheskaia meditsina, 1998, vol. 76, no. 12, p. 30−5 |
Active substance: DILTIAZEM |
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Document reference: 26117 |
Study title: Benefit/risk ratio of the antihistamines (H1-receptor antagonists) terfenadine and chlorpheniramine in children. |
Active substance: CHLORPHENAMINE AND PARACETAMOL |
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Document reference: 24038 |
Study title: bronchodilator effect of two inhaled H1-receptor antagonists, clemastine and chlorpheniramine, in wheezy school-children. |
Active substance: CHLORPHENAMINE AND PARACETAMOL |
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Document reference: 24042 |
Study title: Clinical pharmacology of the H1-receptor antagonists cetirizine and loratadine in children. |
Active substance: CETIRIZINE |
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Document reference: 23718 |
Study title: Benefit/risk ratio of the antihistamines (H1-receptor antagonists) terfenadine and chlorpheniramine in children. |
Active substance: CHLORPHENAMINE AND TRAMAZOLINE |
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Document reference: 24058 |
Study title: bronchodilator effect of two inhaled H1-receptor antagonists, clemastine and chlorpheniramine, in wheezy school-children. |
Active substance: CHLORPHENAMINE AND TRAMAZOLINE |
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Document reference: 24059 |
Study title: A multicenter, randomized, double-blind, placebo-controlled, parallel study of the efficacy and safety of chlorofluorocarbon (CFC) and HFA-227 (non-CFC) formulations of Intal® (cromolyn sodium) metered dose inhaler (MDI) 2mg Qid in the treatment of asthma in patients 12 years and older using PRN β2agonists administered by MDI - Dr M.N. Blumenthal et al. - 1995 to 1996 - Intal 1mg HFA-227, volume 4 Tabulated Study Reports - 2000 - |
Active substance: CROMOGLICIC ACID |
Study summary document link (including results): PNI 10402509.pdf |
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Document reference: 24659 |
Study title: A multicenter, randomized, double-blind, placebo-controlled, parallel study of the efficacy and safety of chlorofluorocarbon (CFC) and non-CFC formulations of Intal® (cromolyn sodium) metered dose inhaler (MDI) 2 mg QID in the treatment of asthma in patients 12 years and older using PRN β2 agonists administered by MDI |
Active substance: CROMOGLICIC ACID |
Study summary document link (including results): PNI 10402508.pdf |
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Document reference: 24667 |
Study title: McDonnell M, Evans N. Upper and lower gastrointestinal complications with dexamethasone despite H2 antagonists. J Paediatr Child Health 1995;31:152-154. |
Active substance: DEXAMETHASONE |
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Document reference: 25687 |
Study title: Placebo-Controlled Efficacy and Safety Study of a Once-Daily, PM Regimen of Mometasone Furoate (SCH 32088) Dry Powder in Asthmatics Previously Maintained on Short-acting Inhaled Beta-agonists |
Active substance: MOMETAZONE |
Study summary document link (including results): C98-475_mometasone furoates.pdf |
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Document reference: 48179 |
Study title: Albano MCC, Latronico AC, Arnhold IJP, Domenice S, Bloise W, Mendonca BB. Long-acting gonadotropin-releasing hormone agonists in the differential diagnosis of male precocious puberty. Journal of Pediatric Endocrinology and Metabolism 10(5)()(pp 499-503), 1997 Date of Publication: 1997 1997;(5):499-503.Albano MCC, Latronico AC, Arnhold IJP, Domenice S, Bloise W, Mendonca BB. Long-acting gonadotropin-releasing hormone agonists in the differential diagnosis of male precocious puberty. Journal of Pediatric Endocrinology and Metabolism 10(5)()(pp 499-503), 1997 Date of Publication: 1997 1997;(5):499-503. |
Active substance: GOSERELIN |
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Document reference: 29000 |
Study title: Breyer P, Haider A, Pescovitz O. Gonadotropin-releasing hormone agonists in the treatment of girls with central precocious puberty. Clinical Obstetrics and Gynecology 1993; 36(3):764-772.Breyer P, Haider A, Pescovitz O. Gonadotropin-releasing hormone agonists in the treatment of girls with central precocious puberty. Clinical Obstetrics and Gynecology 1993; 36(3):764-772. |
Active substance: GOSERELIN |
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Document reference: 29004 |