- Trials with a EudraCT protocol (14,030)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (399)
Query did not match any clinical trials.
| 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: Assessment of efficacy and tolerability of Acarbose in children under 16 years |
| Active substance: ACARBOSE |
| Study summary document link (including results): Bayer Pharma_Acarbose_9981_study_synopsis.pdf |
| View full study record |
| Document reference: 46160 |
| 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: Clinical Study to Investigate the Efficacy and Tolerability of Acarbose (BAY g 5421) Versus Placebo in Diabetic Children (PH 23433) |
| Active substance: ACARBOSE |
| Study summary document link (including results): Bayer Pharma_Acarbose_0634_study_synopsis.pdf |
| View full study record |
| Document reference: 46155 |
| Study title: Double-Blind, Cross-Over Clinical Study at a Single Centre to Compare Acarbose (BAY g 5421) with Placebo in Respect of Efficacy and Tolerability in Patients with Cystic Fibrosis and Pathological Glucose Tolerance (Pilot Study)(PH-26068) |
| Active substance: ACARBOSE |
| Study summary document link (including results): Bayer Pharma_Acarbose_0696_study_synopsis.pdf |
| View full study record |
| Document reference: 46159 |
| Study title: Clinical report on the efficacy and tolerability of Solmucol syrup in paediatric patients suffering from bronchitis |
| Active substance: ACETYLCYSTEINE |
| Study summary document link (including results): ACETYLCYSTEINE_Synopsis.doc |
| View full study record |
| Document reference: 47525 |
| Study title: A Study of the Pharmacology Profile, Safety and Tolerability of Intravenously Administered Single Doses of MK0787/MK0791 in Neonates. |
| Active substance: ALBENDAZOLE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46319 |
| Study title: US - MULTICENTRIC OPEN CLINICAL STUDY OF THE EFFICACY AND TOLERABILITY OF ADAPALENE 0.1% GEL IN PATIENTS WITH ACNE VULGARIS - PORTUGAL/BRAZIL |
| Active substance: ADAPALENE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46269 |
| Study title: PMS Tolerability of the highly dosed seasonal Ultra-Rush immunotherapy with STALORAL300 |
| Active substance: allergen extracts from birch/alder/hazel |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39780 |
| Study title: AN OPEN-LABEL STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF XANAX XR IN THE TREATMENT OF ADOLESCENTS WITH PANIC DISORDER OR ANXIETY WITH PANIC ATTACKS |
| Active substance: ALPRAZOLAM |
| Study summary document link (including results): A6131004 PhRMA Web Synopsis.pdf |
| View full study record |
| Document reference: 47136 |
| Study title: Kinetic and tolerability of injectable ambroxol in children with cystic fibrosis. |
| Active substance: AMBROXOL |
| Study summary document link (including results): Ambroxol Hydrochloride_U87-0661_Synopsis.pdf |
| View full study record |
| Document reference: 46539 |
| Study title: Post Marketing surveillance on tolerability of high dose ambroxol in pregnant women and newborns and on efficacy in preventing IRDS. |
| Active substance: AMBROXOL |
| Study summary document link (including results): Ambroxol Hydrochloride_U93-0189_Synopsis.pdf |
| View full study record |
| Document reference: 46550 |
| Study title: Efficacy and tolerability of the syrup form of a new combination preparation (Clenbuterol, 0.005 mg, and ambroxol, 7.5 mg/ml) in children with obstructive diseases of the respiratory tract. |
| Active substance: AMBROXOL AND CLENBUTEROL |
| Study summary document link (including results): ambroxol_hydrochloride_clenbuterol_hydrochloride_U84-0428_synopsis.pdf |
| View full study record |
| Document reference: 46558 |
| Study title: Clinical repprt on the efficacy and tolerability of ambroxol acefyllinate (Ambromucil) syrup in paediatric patients suffering from chronic asthmatic bronchitis. Controlled study vs ambroxol |
| Active substance: AMBROXOL |
| Study summary document link (including results): Ambroxol Acefyllinate_synopsis.doc |
| View full study record |
| Document reference: 47530 |
| Study title: Efficacy and tolerability of Ambroxol Lozenges 20mg in relieving the pain of sore throat in adolescent patients with acute viral pharyngitis – A randomised, double-blind, placebo-controlled parallel group... |
| Active substance: AMBROXOL |
| Study summary document link (including results): |
| View full study record |
| Document reference: 46555 |
| Study title: Theophylline retard capsules, 250 mg. Efficacy, tolerability and steady-state serum concentrationTheophylline retard capsules, 250 mg. Efficacy, tolerability and steady-state serum concentration |
| Active substance: AMINOPHYLLINE + THEOPHYLLINE |
| Study summary document link (including results): Study report 84-83 Theophylline - synopsis German.pdf |
| View full study record |
| Document reference: 46563 |
| Study title: An Extension of Trial 1033US/0006 to Assess the Safety, Tolerability and Efficacy of Anastrozole (ZD1033, Arimidex™) in the Treatment of Gynecomastia in Pubertal Boys Given Placebo in Trial 1033US/0006 and to Conduct a Long-Term Safety Follow-Up of Non-Responding Subjects Given Anastrozole in the Previous Trial |
| Active substance: ANASTROZOLE |
| Study summary document link (including results): 1033US0016 CSR Synopsis.pdf |
| View full study record |
| Document reference: 21805 |
| Study title: Clinical report on the efficacy and tolerability of amoxicillin in paediatric patients with upper respiratory tract bacterial infections |
| Active substance: AMOXICILLIN |
| Study summary document link (including results): Amoxicillin_Synopsis.doc |
| View full study record |
| Document reference: 47529 |
| Study title: A randomized, investigator-blinded, multicenter, parallel-group study to compare efficacy, safety and tolerability of Coartem dispersible tablet formulation vs. Coartem 6-dose crushed tablet in the treatment of acute uncomplicated Plasmodium falciparum malaria in infants and children. Study CCOA566B2303, Novartis Pharma AG. Basel, Switzerland. 10 Aug 2007 |
| Active substance: ARTEMETHER + LUMEFANTRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 21847 |
| Study title: Open label, multi-center, non-comparative efficacy, safety and tolerability study of Coartem®/Riamet® in the treatment of acute uncomplicated Plasmodium falciparum malaria in non-immune patients. Study CCOA566A2401, Novartis Pharma AG. Basel, Switzerland. 23 Sep 2005. |
| Active substance: ARTEMETHER + LUMEFANTRINE |
| Study summary document link (including results): |
| View full study record |
| Document reference: 21845 |
| Study title: An Open-label Study on Effectiveness and Tolerability of Atomoxetine as Perceived by Patients, Parents, and Physicians in Children with Attention-Deficit/Hyperactivity Disorder in Germany |
| Active substance: ATOMOXETINE |
| Study summary document link (including results): atomoxetine B4Z-SB-LYDD - clinical study summary.pdf |
| View full study record |
| Document reference: 21983 |
