- Trials with a EudraCT protocol (1,385)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (75)

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: 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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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Document reference: 39731 |
Study title: Nuti R, Vattimo A, Turchetti V, Righi G. 25-Hydroxycholecalciferol as an antagonist of adverse corticosteroid effects on phosphate and calcium metabolism in man. J Endocrinol Invest. 1984 Oct;7(5):445-8. Nuti R, Vattimo A, Turchetti V, Righi G. 25-Hydroxycholecalciferol as an antagonist of adverse corticosteroid effects on phosphate and calcium metabolism in man. J Endocrinol Invest. 1984 Oct;7(5):445-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43980 |
Study title: Tc-99m MDP uptake secondary to soft tissue extravasation of calcium gluconate in a newborn thought to have osteomyelitis. Orellana P, Velasquez C, Meneses L, Urioste A, Carreño JE, Garcíia CJ, Sabroso F, Cruces P. Clin Nucl Med. 2002 Sep;27(9):653-5. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44246 |
Study title: Comparative study of angiotensin converting enzyme inhibitor and calcium channel blocker in the treatment of steroid−resistant idiopathic nephrotic syndrome.Kumar NS, Singh A K, Mishra RN, Prakash J. The Journal of the Association of Physicians of India, Jun 2004, vol. 52, p. 454−8, Comparative study of angiotensin converting enzyme inhibitor and calcium channel blocker in the treatment of steroid−resistant idiopathic nephrotic syndrome.Kumar NS, Singh A K, Mishra RN, Prakash J. The Journal of the Association of Physicians of India, Jun 2004, vol. 52, p. 454−8, |
Active substance: VERAPAMIL |
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Document reference: 45535 |
Study title: Lechenie sindroma Reino blokatorami vkhoda kal'tsiia. (Treatment of Raynaud's syndrome with calcium entry blockers).Shcherbakov AB, Guseva NG, Mach ES. Terapevticheskii arkhiv, 1987, vol. 59, no. 4, p. 89−92, Lechenie sindroma Reino blokatorami vkhoda kal'tsiia. (Treatment of Raynaud's syndrome with calcium entry blockers).Shcherbakov AB, Guseva NG, Mach ES. Terapevticheskii arkhiv, 1987, vol. 59, no. 4, p. 89−92, |
Active substance: VERAPAMIL |
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Document reference: 45562 |
Study title: Lee WT, Leung SS, Wang SH, Xu YC, Zeng WP, Lau J, Oppenheimer SJ, Cheng JC. Double-blind, controlled calcium supplementation and bone mineral accretion in children accustomed to a low-calcium diet. Am J Clin Nutr. 1994 Nov; 60(5):744-50. Lee WT, Leung SS, Wang SH, Xu YC, Zeng WP, Lau J, Oppenheimer SJ, Cheng JC. Double-blind, controlled calcium supplementation and bone mineral accretion in children accustomed to a low-calcium diet. Am J Clin Nutr. 1994 Nov; 60(5):744-50. |
Active substance: CALCIUM CARBONATE |
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Document reference: 23155 |
Study title: Clinical experimentation of calcium bucloxate (804 CB) in rheumatologya |
Active substance: INDOMETHACIN |
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Document reference: 29834 |
Study title: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non Hormonal Contraceptive Users |
Active substance: MEDROXYPROGESTERONE ACETATE |
Study summary document link (including results): A6791022 PhRMA Web Synopsis.pdf |
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Document reference: 48025 |
Study title: Troubles during dentition. Study concerning treatment with a homeopatic complex preparation |
Active substance: Magnesium phosphoricum C6, Chamomilla recutita D6, Calcium carbonicum C8, Passiflora D6 |
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Document reference: 40066 |
Study title: Karimeddini MK, Spencer RP. Bone agent and radiogallium deposition around infiltrated calcium gluconate. Clin Nucl Med. 1993 Sep;18(9):797-8. No abstract available. Karimeddini MK, Spencer RP. Bone agent and radiogallium deposition around infiltrated calcium gluconate. Clin Nucl Med. 1993 Sep;18(9):797-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43651 |
Study title: Antagonisty kal'tsiia v lechenii nefrogennoi gipertenzii. (Calcium antagonists in the treatment of nephrogenic hypertension).Antonchenko IV, Tareeva IE, Kutyrina IM, Galstian GM, Rogov VA. Klinicheskaia meditsina, Aug 1990, vol. 68, no. 8, p. 52−6,Antagonisty kal'tsiia v lechenii nefrogennoi gipertenzii. (Calcium antagonists in the treatment of nephrogenic hypertension).Antonchenko IV, Tareeva IE, Kutyrina IM, Galstian GM, Rogov VA. Klinicheskaia meditsina, Aug 1990, vol. 68, no. 8, p. 52−6, |
Active substance: VERAPAMIL |
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Document reference: 45555 |
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. 30−5, 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. 30−5, |
Active substance: VERAPAMIL |
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Document reference: 45542 |
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. 205−11, 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. 205−11, |
Active substance: VERAPAMIL |
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Document reference: 45543 |
Study title: Calcium channel blockers in cirrhotic patients with portal hypertension.Li D, Lu H, Li X, Quan Q, Li X, Lu W. Chinese medical journal, Nov 1995, vol. 108, no. 11, p. 803−8, Calcium channel blockers in cirrhotic patients with portal hypertension.Li D, Lu H, Li X, Quan Q, Li X, Lu W. Chinese medical journal, Nov 1995, vol. 108, no. 11, p. 803−8, |
Active substance: VERAPAMIL |
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Document reference: 45547 |
Study title: A 30-Week, Forced-titration and Randomised, Crossover, Multicentre, Multinational Trial to Evaluate the Efficacy and Safety of rosuvastatin and Atorvastatin in Subjects with Homozygous Familial Hypercholesterolaemia (4522IL/0054): Full Report of the First 18 Weeks (forced-titration) and Last 12 Weeks of Treatment (crossover period) for Efficacy and for Safety |
Active substance: ROSUVASTATIN CALCIUM |
Study summary document link (including results): Study 4522IL0054_CSR Synopsis.pdf |
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Document reference: 47886 |
Study title: Pharmacokinetics of Rosuvastatin in Children and Adolescents with Heterozygous Familial Hypercholesterolemia (4522IL/0086) |
Active substance: ROSUVASTATIN CALCIUM |
Study summary document link (including results): Study 4522IL0086_CSR Synopsis.pdf |
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Document reference: 47885 |