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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease

Brief 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.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Proportion of responders in each of the two Pasireotide LAR (long acting release)regimens independently [ Time Frame: 7 months ]

To assess the efficacy of two Pasireotide LAR (long acting release) regimens independently in patients with Cushing's disease after 7 months of treatment regardless of up titration at month 4. A responder is defined as a patient who attains Mean Urinary Free Cortisol (mUFC) ≤ 1.0 X Upper Limit of Normal (ULN) at month 7 regardless of dose-titration.


Original Primary Outcome: Proportion of responders in each of the two Pasireotide LAR (long acting release)regimens independently [ Time Frame: 7 months ]

To assess the efficacy of two Pasireotide LAR (long acting release) regimens independently in patients with Cushing's disease after 7 months of treatment regardless of up titration at month 4. A responder is defined as a patient who attains mUFC ≤ 1.0 X ULN at month 7 regardless of dose-titration.


Current Secondary Outcome:

  • Proportion of responders in each of the Pasireotide LAR (long acting release) 10 mg and 30 mg doses independently in patients with Cushing's disease after 7 months of treatment who did not up titrate the doses of Pasireotide at month 4. [ Time Frame: 7 months ]
    A responder is defined as a patient who attains mUFC ≤1.0 X ULN and had not had a dose increase at Month 4.
  • Change in mean urinary free cortisol from baseline at every month in the core and every 3 months in extension within the two Pasireotide LAR regimens [ Time Frame: 26 months ]
  • Proportion of responders in the two Pasireotide LAR regimens at every month in the core and every 3 months in the extension phases [ Time Frame: 26 months ]
  • Proportion of responders in the two Pasireotide LAR regimens as measured by controlled and partially controlled mUFC(mean urinary free cortisol) combined responders at every month in the core and every 3 months in the extension [ Time Frame: 26 months ]
  • Controlled mUFC (mean urinary free cortisol)response of the two Pasireotide regimens by month 7 and 12 [ Time Frame: 12 months ]
    To evaluate the frequency of controlled mUFC response of the two Pasireotide regimens by month 7 and 12.


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: June 14, 2011
Date Started: November 4, 2011
Date Completion:
Last Updated: March 30, 2017
Last Verified: March 2017