WHO ICTRP trial
Study on the effectiveness and safety of the treatment of hyponatremia due to…
EUCTR2012-004071-39-IT · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2012-004071-39-IT |
|---|---|
| Public title | Study on the effectiveness and safety of the treatment of hyponatremia due to inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid restriction in patients affected by pituitary disorders. |
| Scientific title | Study on the effectiveness and safety of the treatment of mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid restriction in patients who underwent transsphenoidal surgery for hypothalamic-pituitary disorders. |
| Primary sponsor | FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Countries | Italy |
| Conditions | Mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH) MedDRA version: 14.1 Level: SOC Classification code 10014698 Term: Endocrine disorders System Organ Class: 10014698… |
| Interventions | Trade Name: SAMSCA*10CPR 15MG Pharmaceutical Form: Tablet INN or Proposed INN: TOLVAPTAN CAS Number: 150683-30-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- |
| Registration date | Oct 31, 2012 |
| Secondary IDs | TOLV2012 |
| Registry page | clinicaltrialsregister.eu |
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: