- Trials with a EudraCT protocol (1,385)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (75)
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: Wallot M, Bonzel KE, Winter A, Geörger B, Lettgen B, Bald M. Calcium acetate versus calcium carbonate as oral phosphate binder in pediatric and adolescent hemodialysis patients. Pediatr Nephrol. 1996 Oct; 10(5):625-30. Wallot M, Bonzel KE, Winter A, Geörger B, Lettgen B, Bald M. Calcium acetate versus calcium carbonate as oral phosphate binder in pediatric and adolescent hemodialysis patients. Pediatr Nephrol. 1996 Oct; 10(5):625-30. |
| Active substance: CALCIUM CARBONATE |
| Study summary document link (including results): |
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| Document reference: 23156 |
| Study title: Xu Y, Kangmin WU, Zheng AN, et al. Effect of calcium carbonate supplementation on preschool children. Chinese J Clin Nutr, 2000; 8: 268-272.Xu Y, Kangmin WU, Zheng AN, et al. Effect of calcium carbonate supplementation on preschool children. Chinese J Clin Nutr, 2000; 8: 268-272. |
| Active substance: CALCIUM CARBONATE |
| Study summary document link (including results): |
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| Document reference: 23172 |
| Study title: Avioli L.V., McDonald J.E. and Lee S.W.(1965): The influence of age on the intestinal absorption of 47Ca in women and its relation to 47Ca absorption in postmenopausal osteoporosis. Journal of Clinical Investigation 44(12): 1960-7. |
| Active substance: CALCIUM COMBINATIONS |
| Study summary document link (including results): |
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| Document reference: 23177 |
| Study title: Cameron MA, Paton LM, Nowson CA, et al. The effect of calcium supplementation on bone density in premenarcheal females: a co-twin approach. J Clin Endocrinol Metab 2004; 89: 4916-4922 |
| Active substance: CALCIUM COMBINATIONS |
| Study summary document link (including results): |
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| Document reference: 23173 |
| Study title: Fujisawa Y., Kida K. and Matsuda H. (1984): Role of change in vitamin D metabolism with age in calcium and phosphorus metabolism in normal human subjects. Journal of Clinical Endocrinology and Metabolism 59: 719-26. |
| Active substance: CALCIUM COMBINATIONS |
| Study summary document link (including results): |
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| Document reference: 23178 |
| Study title: Johnston C.C., Miller J.Z., Slemenda C.W., Reister T.K., Hui S., Christian J.C., Peacock: M. (1992): Calcium supplementation and increases in bone mineral density in children. The New England Journal of Medicine 327(2): 82-7. |
| Active substance: CALCIUM COMBINATIONS |
| Study summary document link (including results): |
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| Document reference: 23179 |
| Study title: National Academy of Sciences, Institute of Medicine Dietary Reference Intakes for calcium, phosphorus, magnesium, vitamin D, and fluoride. National Academy Press: Washington, DC, 1997 |
| Active substance: CALCIUM COMBINATIONS |
| Study summary document link (including results): |
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| Document reference: 23174 |
| Study title: US Department of Health and Human Services, Office of the Surgeon General. Bone Health and Osteoporosis A Report of the Surgeon General. Rockville, MD, 2004. |
| Active substance: CALCIUM COMBINATIONS |
| Study summary document link (including results): |
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| Document reference: 23175 |
| Study title: Xu Y, Kangmin WU, Zheng AN, et al. Effect of calcium carbonate supplementation on preschool children. Chinese J Clin Nutr, 2000; 8: 268–272. |
| Active substance: CALCIUM COMBINATIONS |
| Study summary document link (including results): |
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| Document reference: 23176 |
| Study title: Borutta et a_Kariesprotektive Wirksamkeit zweier Fluoridlacke_1991 |
| Active substance: CALCIUM FLUORIDE AND SODIUM FLUORIDE |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication VOCO GmbH_draft Borutta 1991.xls |
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| Document reference: 48019 |
| Study title: Caries prevention by use of fluoride varnish in primary school children in Minsk |
| Active substance: CALCIUM FLUORIDE AND SODIUM FLUORIDE |
| Study summary document link (including results): Caries prevention by use of fluoride varnish in primary school children in Minsk_english.PDF |
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| Document reference: 48020 |
| Study title: Clinical study of Bifluorid 12 |
| Active substance: CALCIUM FLUORIDE AND SODIUM FLUORIDE |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication VOCO GmbH_Goerne.xls |
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| Document reference: 23180 |
| Study title: Die kariesprophylaktische Wirkung von Bifluorid 12 und seiner Wirkstoffe bei Schulkindern |
| Active substance: CALCIUM FLUORIDE AND SODIUM FLUORIDE |
| Study summary document link (including results): Report_Kariesinhibierende Wirkung von Bifluorid 12_4-Jahres-Studie_german.pdf |
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| Document reference: 23181 |
| Study title: Examination of the cariogenic effect of repeated intake of sucrose-containing beverage and prevention by fluoride containing varnishes |
| Active substance: CALCIUM FLUORIDE AND SODIUM FLUORIDE |
| Study summary document link (including results): Report-Bifluorid 12_Plaque screening_QLF inspector_english.pdf |
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| Document reference: 23182 |
| Study title: Open study to compare the caries reducing effect of a chlorhexidine varnish or a flouride varnish topically applied every 3rd month on the incidence of approximal caries in teenagers with a proven susceptibility to interdental enamel caries during a 3-year period.Petersson et al. (Caries Res 2000;34:140-143) |
| Active substance: CALCIUM FLUORIDE AND SODIUM FLUORIDE |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication VOCO GmbH_Sodium flouride, Calcium flouride_2.xls |
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| Document reference: 48185 |
| Study title: Sköld-Larsson et al. (Clin Oral Investig. 2000 Mar;4(1):31-4) |
| Active substance: CALCIUM FLUORIDE AND SODIUM FLUORIDE |
| Study summary document link (including results): EUdraCT_reduced datafields for Interim publication VOCO GmbH_final.xls |
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| Document reference: 47619 |
| Study title: Intraoperative cortical PO2 measurement in kidney transplantation. the effect of the calcium antagonist diltiazem. Urologe A. 1994 Sep;33(5):415-21. Intraoperative cortical PO2 measurement in kidney transplantation. the effect of the calcium antagonist diltiazem. Urologe A. 1994 Sep;33(5):415-21. |
| Active substance: DILTIAZEM |
| Study summary document link (including results): |
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| Document reference: 26105 |
| Study title: Anti−anginal and anti−ischemic effects of mibefradil, a new T−type calcium channel antagonist.Kobrin I, Bieska G, Charlon V, Lindberg E, Pordy R. Cardiology, 1998, vol. 89 Suppl 1, p. 23−32Anti−anginal and anti−ischemic effects of mibefradil, a new T−type calcium channel antagonist.Kobrin I, Bieska G, Charlon V, Lindberg E, Pordy R. Cardiology, 1998, vol. 89 Suppl 1, p. 23−32 |
| Active substance: DILTIAZEM |
| Study summary document link (including results): |
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| Document reference: 26120 |
| 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: Fenomeno di Raynaud e farmaci calcio−antagonisti. Studio preliminare in aperto con flunarizina. (Raynaud's phenomenon and calcium blocking agents. A preliminary open study with flunarizine). Centonze V, Campanale G, Vino M, Caporaletti P, Magrone D, Russo P, Di Bari M, Loragno, Albano O. La Clinica terapeutica, 30 Apr 1991, vol. 137, no. 2, p. 77−82Fenomeno di Raynaud e farmaci calcio−antagonisti. Studio preliminare in aperto con flunarizina. (Raynaud's phenomenon and calcium blocking agents. A preliminary open study with flunarizine). Centonze V, Campanale G, Vino M, Caporaletti P, Magrone D, Russo P, Di Bari M, Loragno, Albano O. La Clinica terapeutica, 30 Apr 1991, vol. 137, no. 2, p. 77−82 |
| Active substance: DILTIAZEM |
| Study summary document link (including results): |
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| Document reference: 26145 |
| Study title: Haemodynamics, cardiac conduction and pharmacokinetics of mibefradil (Ro 40−5967), a novel calcium antagonist. Petrie JR, Glen SK, MacMahon M, Crome R, Meredith PA, Elliott HL, Reid JL. Journal of hypertension, Dec 1995, vol. 13, no. 12 Pt 2, p. 1842−6Haemodynamics, cardiac conduction and pharmacokinetics of mibefradil (Ro 40−5967), a novel calcium antagonist. Petrie JR, Glen SK, MacMahon M, Crome R, Meredith PA, Elliott HL, Reid JL. Journal of hypertension, Dec 1995, vol. 13, no. 12 Pt 2, p. 1842−6 |
| Active substance: DILTIAZEM |
| Study summary document link (including results): |
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| Document reference: 26125 |
| Study title: Intraoperative kortikale PO2−Messungen bei Nierentransplantation. Einfluss des Kalziumantagonisten Diltiazem. (Intraoperative cortical PO2 measurement in kidney transplantation. the effect of the calcium antagonist diltiazem). Schott G, Pröm T. Der Urologe. Ausg. A, Sep 1994, vol. 33, no. 5, p. 415−21Intraoperative kortikale PO2−Messungen bei Nierentransplantation. Einfluss des Kalziumantagonisten Diltiazem. (Intraoperative cortical PO2 measurement in kidney transplantation. the effect of the calcium antagonist diltiazem). Schott G, Pröm T. Der Urologe. Ausg. A, Sep 1994, vol. 33, no. 5, p. 415−21 |
| Active substance: DILTIAZEM |
| Study summary document link (including results): |
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| Document reference: 26135 |
| Study title: Persistence of anti−hypertensive effect after 'missed doses' of calcium antagonist with long (amlodipine) vs short (diltiazem) elimination half−life. Leenen FH, Fourney A, Notman G, Tanner J. British journal of clinical pharmacology, Feb 1996, vol. 41, no. 2, p. 83−8Persistence of anti−hypertensive effect after 'missed doses' of calcium antagonist with long (amlodipine) vs short (diltiazem) elimination half−life. Leenen FH, Fourney A, Notman G, Tanner J. British journal of clinical pharmacology, Feb 1996, vol. 41, no. 2, p. 83−8 |
| Active substance: DILTIAZEM |
| Study summary document link (including results): |
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| Document reference: 26128 |
| Study title: Pharmacokinetic interactions between indinavir plus ritonavir and calcium channel blockers.Glesby MJ, Aberg JA, Kendall MA, Fichtenbaum CJ, Hafner R, Hall S, Grosskopf N, Zolopa AR, Gerber JG. Clinical pharmacology and therapeutics, Aug 2005, vol. 78, no. 2, p. 143−53,Pharmacokinetic interactions between indinavir plus ritonavir and calcium channel blockers.Glesby MJ, Aberg JA, Kendall MA, Fichtenbaum CJ, Hafner R, Hall S, Grosskopf N, Zolopa AR, Gerber JG. Clinical pharmacology and therapeutics, Aug 2005, vol. 78, no. 2, p. 143−53, |
| Active substance: DILTIAZEM |
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| Document reference: 26110 |
| 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 |
| Study summary document link (including results): |
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| Document reference: 26117 |
| Study title: Calcium channel blockers and cardiac mortality in the treatment of hypertension: a report from the Department of Health Hypertension Care Computing Project (DHCCP). Bulpitt CJ, Palmer AJ, Beevers DG, Coles EC, Ledingham JG, Petrie JC, Webster J. Journal of human hypertension, Apr 1997, vol. 11, no. 4, p. 205−11Calcium channel blockers and cardiac mortality in the treatment of hypertension: a report from the Department of Health Hypertension Care Computing Project (DHCCP). Bulpitt CJ, Palmer AJ, Beevers DG, Coles EC, Ledingham JG, Petrie JC, Webster J. Journal of human hypertension, Apr 1997, vol. 11, no. 4, p. 205−11 |
| Active substance: DILTIAZEM |
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| Document reference: 26123 |
| Study title: Calcium channel blockers for prevention of noise trauma in otologic surgery.Maurer J, Mann WJ, Amedee RG. The Journal of the Louisiana State Medical Society : official organ of the Louisiana State Medical Society, Sep 1998, vol. 150, no. 9, p. 400−5.Calcium channel blockers for prevention of noise trauma in otologic surgery.Maurer J, Mann WJ, Amedee RG. The Journal of the Louisiana State Medical Society : official organ of the Louisiana State Medical Society, Sep 1998, vol. 150, no. 9, p. 400−5. |
| Active substance: DILTIAZEM |
| Study summary document link (including results): |
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| Document reference: 26119 |
| Study title: Comparison of the therapeutic effects of the beta−blocking agent bisoprolol and the calcium−blocking agent diltiazem in patients with heart failure due to dilated cardiomyopathy. Suwa M, Ito T, Otake Y, Moriguchi A, Hirota Y, Kawamura K. Japanese circulation journal, Oct 1996, vol. 60, no. 10, p. 767−73Comparison of the therapeutic effects of the beta−blocking agent bisoprolol and the calcium−blocking agent diltiazem in patients with heart failure due to dilated cardiomyopathy. Suwa M, Ito T, Otake Y, Moriguchi A, Hirota Y, Kawamura K. Japanese circulation journal, Oct 1996, vol. 60, no. 10, p. 767−73 |
| Active substance: DILTIAZEM |
| Study summary document link (including results): |
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| Document reference: 26126 |
| Study title: Effect of chronic treatment with the calcium antagonist diltiazem in Duchenne muscular dystrophy.Neurology. 1988 Apr;38(4):609-13 Effect of chronic treatment with the calcium antagonist diltiazem in Duchenne muscular dystrophy.Neurology. 1988 Apr;38(4):609-13 |
| Active substance: DILTIAZEM |
| Study summary document link (including results): |
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| Document reference: 26107 |
| Study title: Pediatric patients treatted in the Rosou Study In the Baxter clinical study 014/015, also published by Rousou, which was the pivotal study of the primary BLA submission, 26 of the randomized patients were below 18 years old (7 days – 16 years). Twenty-one of these patients were in the fibrin sealant group, 5 in the control group. Of the 21 patients in the fibrin sealant group 17 (80.9%) achieved hemostasis within 5 minutes and were rated a success, while of the 5 control patients only 1 (20%) achieved time to hemostasis within 5 minutes. |
| Active substance: FIBRINOGEN 70 - 110 MG/ML + PLASMAFIBRONECTIN 2-9 MG/ML +FACTOR XIII 10-50 U/ML+ PLASMINOGEN 0.04 - 0.12 MG/ML+ APROTININ 3000 KIU/ML+ THROMBIN 4 IU/ML+ THROMBIN 500 IU/ML+ CALCIUM CHLORIDE 5.88 MG/ML |
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| Document reference: 27270 |
| Study title: Clinical report on the efficacy and tolerability of Calisvit in paediatric lymphatic patients |
| Active substance: COLECALCIFEROL AND CALCIUM FLUORIDE |
| Study summary document link (including results): Colecalciferol, Calcium Phos_Synpses.doc |
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| Document reference: 47533 |
| Study title: Meier C, Woitge HW, Witte K, Lemmer B, Seibel MJ. Supplementation with oral vitamin D3 and calcium during winter prevents seasonal bone loss: a randomized controlled open-label prospective trial. J Bone Miner Res. 2004 Aug;19(8):1221-30. |
| Active substance: COLECALCIFEROL AND SODIUM FLUORIDE |
| Study summary document link (including results): |
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| Document reference: 24637 |
| Study title: MRL Clinical Study Report, Multicenter Study: A Randomized, Double-Blind, Parallel, Placebo-Controlled, Pilot Study, Comparing the Onset and Duration of Action of Famotidine 10-mg CCT (Coated-Chewable Tablets), Calcium Carbonate-Magnesium Hydroxide Chewable Antacid Tablets (42 mEq ANC), and Placebo on Symptoms Produced Following an Evening Provocative Meal. |
| Active substance: FAMOTIDINE COMBINATIONS |
| Study summary document link (including results): |
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| Document reference: 27011 |
| Study title: Laporte S, Mismetti P, Piquet P, Doubine S, Touchot A, Decousus H. Population pharmacokinetic of nadroparin calcium (Fraxiparine) in children hospitalised for open heart surgery. European Journal of Pharmaceutical Sciences 1999;8:119-25." EJPS 1999:8:119-25 |
| Active substance: NADROPARIN |
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| Document reference: 32448 |
| Study title: Graybill J. Bone radiography and serum calcium and phosphorus levels during itraconazole treatment in a young patient with progressive coccidioidomycosis. Clinical research report on R051211 no-66, June 1987. (1.5 years, LMD56178)Graybill J. Bone radiography and serum calcium and phosphorus levels during itraconazole treatment in a young patient with progressive coccidioidomycosis. Clinical research report on R051211 no-66, June 1987. (1.5 years, LMD56178) |
| Active substance: ITRACONAZOLE |
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| Document reference: 30806 |
| Study title: Preoperative UFT and calcium folinate and radiotherapy in rectal cancer. Hoff PM et al. Oncology (Williston Park). 1999 Jul;13(7 Suppl 3):129-31 |
| Active substance: FLUOROURACIL |
| Study summary document link (including results): |
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| Document reference: 28309 |
| Study title: UFT plus calcium folinate/irinotecan in colorectal cancer. Twelves C. Oncology (Williston Park). 1999 Jul;13(7 Suppl 3):51-4 |
| Active substance: FLUOROURACIL |
| Study summary document link (including results): |
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| Document reference: 28310 |
| Study title: AN OPEN-LABEL STUDY OF INTRAVENOUS FOSPHENYTOIN (CEREBYX) ON PLASMA FORMATE, PHOSPHATE, AND CALCIUM CONCENTRATIONS IN NEONATAL PEDIATRIC PATIENTS |
| Active substance: FOSPHENYTOIN |
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| Document reference: 28605 |
| Study title: Calcium homeostasis and hypercalciuria in hyperprostaglandin E syndrome. |
| Active substance: INDOMETHACIN |
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| Document reference: 29826 |
| Study title: Observational study Angina-Gastreu N R1 |
| Active substance: (HMP) Apis D4, Belladonna D4, Calcium iodatum D4, Hepar sulfuris D12, Kalium bichromicum D4, Lachesis D12, Marum verum D6, Mercurius sublimatus corrosivus D5, Phytolacca D4 |
| Study summary document link (including results): |
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| Document reference: 39731 |
