open, non comparative, prospectic, phase IV clinical study to evaluate the activity and tolerance of Cinacalcet-HCl (drug name Mimpara) in patients affected by MEN1-associated primary hyperparathyroid...

Mise à jour : Il y a 5 ans
Référence : EUCTR2009-009502-79

open, non comparative, prospectic, phase IV clinical study to evaluate the activity and tolerance of Cinacalcet-HCl (drug name Mimpara) in patients affected by MEN1-associated primary hyperparathyroidism

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Extrait

To study the activities of Cinacalcet- HCl administered to patients with MEN1-associated primary hyperparathyroidism (plasma PTH> 7.6 pmol / ml or 70 pg / ml and total serum calcium> 10.3 mg / dl or 2.57 mmol / l) at doses of 30 mg 1-2 times / day (starting with 30 mg per day, increasing the dose to 30 mg 2 times day, up to a maximum of 40-50 mg 2 times per day, if at the next inspection calcemia was still greater than 10.3 mg / dl or 2.57 mmol / l), considering: a) reduction or normalization of the levels of PTH and calcium; b) reducing or maintaining the size of parathyroid tissue affected


Critère d'inclusion

  • Primary hyperparathyroidism in patients with MEN1

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