- Trials with a EudraCT protocol (227)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (9)
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: A Phase III, Prospective, Placebo-Controlled, Double-Blinded, Randomized, Multi-Center Study to Determine the Safety and Efficacy of Calcijex® (Calcitriol Injection) in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric End Stage Renal Disease Patients on Hemodialysis |
| Active substance: CALCITRIOL |
| Study summary document link (including results): Calcitriol-1999007.pdf |
| View full study record |
| Document reference: 47097 |
| Study title: Salusky IB, Goodman WG, Sahney S, Gales B, Perilloux A, Wang HJ, Elashoff RM, Jüppner H. Sevelamer controls parathyroid hormone-induced bone disease as efficiently as calcium carbonate without increasing serum calcium levels during therapy with active vitamin D sterols. J Am Soc Nephrol. 2005 Aug; 16(8):2501-8. Epub 2005 Jun 8. Salusky IB, Goodman WG, Sahney S, Gales B, Perilloux A, Wang HJ, Elashoff RM, Jüppner H. Sevelamer controls parathyroid hormone-induced bone disease as efficiently as calcium carbonate without increasing serum calcium levels during therapy with active vitamin D sterols. J Am Soc Nephrol. 2005 Aug; 16(8):2501-8. Epub 2005 Jun 8. |
| Active substance: CALCIUM CARBONATE |
| Study summary document link (including results): |
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| Document reference: 23163 |
| Study title: Prevalence of goitre and hypothyroidism in Southern Tanzania: Effect of iodised oil on thyroid hormone deficiency. |
| Active substance: Ethyl esters of iodized fatty acids of poppy seed oil |
| Study summary document link (including results): |
| View full study record |
| Document reference: 39970 |
| Study title: Effect of oral iodized oil on thyroid size and thyroid hormone metabolism in children with concurrent selenium and iodine deficiency. ; Zimmermann-M-B. European Journal of Clinical Nutrition, 2000, Vol /Iss/Pg. 54/3 (209-213)Effect of oral iodized oil on thyroid size and thyroid hormone metabolism in children with concurrent selenium and iodine deficiency. ; Zimmermann-M-B. European Journal of Clinical Nutrition, 2000, Vol /Iss/Pg. 54/3 (209-213) |
| Active substance: IODINE |
| Study summary document link (including results): |
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| Document reference: 30234 |
| Study title: Prevalence of goitre and hypothyroidism in Southern Tanzania: Effect of iodised oil on thyroid hormone deficiency. ; Wachter-W. Journal of Epidemiology and Community Health, 1986, Vol/Iss/Pg. 40/1 (86-91)Prevalence of goitre and hypothyroidism in Southern Tanzania: Effect of iodised oil on thyroid hormone deficiency. ; Wachter-W. Journal of Epidemiology and Community Health, 1986, Vol/Iss/Pg. 40/1 (86-91) |
| Active substance: IODINE |
| Study summary document link (including results): |
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| Document reference: 30311 |
| Study title: Influence of timing and dose of thyroid hormone replacement on development in infants with congenital hypothyroidismJ Pediatr 2000; 136: 292-297 Bongers-Schokking JJ., 2000 |
| Active substance: LEVOTHYROXINE |
| Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
| View full study record |
| Document reference: 48982 |
| Study title: A Phase IV, Double-Blind, Placebo-Controlled, Multi-Center Study to Determine the Safety and Effectiveness of Zemplar in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric End Stage Renal Disease Subjects on Hemodialysis |
| Active substance: PARICALCITOL |
| Study summary document link (including results): Paricalcitol-2001022.pdf |
| View full study record |
| Document reference: 45819 |
| Study title: Colls F. et.al, Changes in plasma thyroid hormones levels after a single dose of triiodothyronine in prmature infants of less than 30 weeks gestational age, Eur. J. Endocrinology 143, 733-740, 2000 |
| Active substance: LIOTHYRONINE |
| Study summary document link (including results): |
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| Document reference: 47215 |
| Study title: Aktas A, Elahi N. Bone scan findings in patients with chronic renal failure having symptoms related to bone: correlation with parathyroid hormone levels. Transplant Proc. 1999 Dec;31(8):3309-11. No abstract available. Aktas A, Elahi N. Bone scan findings in patients with chronic renal failure having symptoms related to bone: correlation with parathyroid hormone levels. Transplant Proc. 1999 Dec;31(8):3309-11. No abstract available. |
| Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
| Study summary document link (including results): |
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| Document reference: 43498 |
