WHO ICTRP trial

Acromegaly is a syndrome that results when the pituitary gland produces excess…

EUCTR2010-021008-77-SE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2010-021008-77-SE
Public title Acromegaly is a syndrome that results when the pituitary gland produces excess growth hormone. It most commonly affects adults in middle age. Acromegaly is often also associated with gigantism.
Scientific title A MULTI - CENTER OPEN LABEL PHASE II (B) STUDY TO ASSESS EFFECTS OF SOM230 ON CARDIOVASCULAR PARAMETERS IN ACROMEGALIC PATIENTS - PASIREOTIDE/01/2010 (CSOM230CSE01T)
Primary sponsor Göteborgs Universitet, Göteborg Sweden
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Netherlands;Italy;Sweden
Conditions Adult patients 18 to 80 years of age with diagnosed acromegaly eligible for treatment with a somatostatin analogue and not on previous pharmacological treatment for acromegaly.;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Interventions Product Name: PASIREOTIDE Product Code: SOM230 Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: Pasireotide Current Sponsor code: SOM230 Concentration unit: IU/mg international unit(s)/milligram…
Registration date May 23, 2011
Target size 20
Secondary IDs PASIREOTIDE/01/2010
Registry page clinicaltrialsregister.eu

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