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NCT01374906 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

A Phase 3 study of Cushing's Disease, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
150
Enrollment target
20
Study locations

NCT01374906: Completed Phase 3 study of Cushing's Disease, sponsored by Novartis Pharmaceuticals.

NCT01374906 is a Phase 3 study of Cushing's Disease that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 150 participants, above the 102-participant average among 5 other Cushing's Disease trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01374906, a Phase 3 study of Cushing's Disease, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
150 participants
Enrollment target
20
Study locations

Study Summary

This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

Primary Outcome

Percentage of participants that attained a mean urinary free cortisol (mUFC) \<= 1.0 x upper limit of normal (ULN) at Month 7 regardless of dose up-titration at Month 4. Patients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.

Conditions Studied

Cushing's Disease

Interventions

  • DRUG pasireotide LAR
  • DRUG SOM230 LAR 30 mg
  • DRUG SOM230 LAR 10 mg

Study Locations (20)

Other

  • Novartis Investigative Site - Buenos Aires
  • Novartis Investigative Site - Córdoba
  • Novartis Investigative Site - Brussels
  • Novartis Investigative Site - Ghent
  • Novartis Investigative Site - Leuven

California

  • University of California at Los Angeles UCLA Tiverton - Los Angeles
  • Harbor-UCLA Medical Center LA Biomed - Torrance

Arizona

  • ClinTriCo - Phoenix

Georgia

  • Emory University School of Medicine/Winship Cancer Institute G2304 - C2301 - Atlanta

Maryland

  • Pituitary Center, Division of Endocrinology SC - Baltimore

Michigan

  • University of Michigan Comprehensive Cancer Center SC-2 - Ann Arbor

New York

  • Mount Sinai School of Medicine Mt. Sinai Medical Center - New York

Oregon

  • Oregon Health & Sciences University DeptofOregonHealth&Sciences(2) - Portland

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2011-11-04
Est. Completion 2016-12-21
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT01374906 record still lists

NCT01374906 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 102-participant average among 5 other Cushing's Disease trials with a reported enrollment target (47% higher).

The record links to 1 condition, with Cushing's Disease appearing as the primary indexed condition, and to 3 interventions - of which pasireotide LAR is the first listed.

NCT01374906 names 20 study sites across 15 states, led by Other, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT01374906 about?

NCT01374906 is a clinical study titled "Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease". This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

What is the current status of trial NCT01374906?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2011-11-04. Estimated completion is 2016-12-21.

What conditions does trial NCT01374906 study?

This clinical trial studies the following conditions: Cushing's Disease.

What interventions are being tested in trial NCT01374906?

The interventions under investigation include: pasireotide LAR (DRUG), SOM230 LAR 30 mg (DRUG), SOM230 LAR 10 mg (DRUG).

Who is sponsoring clinical trial NCT01374906?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01374906 being conducted?

This trial has 20 study locations across Arizona, California, Georgia, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT01374906, the US trial registry maintained by the National Library of Medicine. NCT01374906 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.