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An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly

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Novartis

Status and phase

Completed
Phase 2

Conditions

Acromegaly

Treatments

Drug: Pasireotide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00171730
CSOM230B2201E1
2004-002849-12 (EudraCT Number)

Details and patient eligibility

About

Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.

Enrollment

30 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants who have completed all four treatment regimens in the core study CSOM230B2201 (NCT00088582) and achieved biochemical control in growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels after at least one month of pasireotide administration at any of the three doses.
  • Participants who did not experience any unacceptable adverse events or tolerability issues during the core study CSOM230B2201.

Exclusion criteria

  • Participants who experienced or developed compression of the optic chiasm causing any visual field defect during the core study CSOM230B2201.
  • Participants who required a surgical intervention for relief of any sign or symptom associated with tumor compression during the core study CSOM230B2201.
  • Participants who experienced or developed congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation or acute myocardial infraction during the core study CSOM230B2201.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Pasireotide s.c. Overall
Experimental group
Description:
Participants received pasireotide as a daily subcutaneous (s.c) injection, every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 microgram (μg)) for as long as the participant benefited from the treatment, and there were no safety or tolerability concerns (median duration of 22.7 months).
Treatment:
Drug: Pasireotide

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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