Clinical Trial: Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly
Brief Summary:
The patients will receive either Pasireotide LAR or Octreotide LAR for one year of treatment.
The objective of this study is to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.
Following one year of treatment patients may proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) will be switched to the other treatment arm at month 13.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Compare the Proportion of Patients With a Reduction of Mean GH Level to <2.5 ug/L and the Normalization of IGF-1 Between the Two Teatments Groups [ Time Frame: 12 months ]
Original Primary Outcome: Mean growth hormone (GH) level and insulin like growth factor-1 (IGF-1) level,12 months.
Current Secondary Outcome:
- Effect of Pasireotide LAR vs. Octreotide LAR on Reduction of GH to <2.5 ug/L Alone [ Time Frame: 12 Months ]
- Effect of Pasireotide LAR vs. Octreotide LAR on Tumor Volume [ Time Frame: 12 Months ]
- Effect of Pasireotide LAR vs. Octreotide LAR on Health Related Quality of Life [ Time Frame: 12 Months ]
- Effect of Pasireotide LAR vs. Octreotide LAR as Long Term Treatment and After Cross-over on the Proportion of Patients With a Reduction of Mean GH Level to <2.5 ug/L and Nomalization of IGF-1 to Within Normal Limits (Age and Sex Related) [ Time Frame: 12 Months ]
- Effect of Pasireotide LAR and Octreotide LAR as Long Term Treatment and After Cross Over on (i)GH<2.5 ug/L and (ii) Normalized IGF-1 [ Time Frame: 12 Months ]
Original Secondary Outcome: compare the effect of Pasireotide LAR and Octreotide LAR on change from baseline in mean growth hormone at 12 months of treatment
Information By: Novartis
Dates:
Date Received: January 14, 2008
Date Started: February 2008
Date Completion:
Last Updated: May 23, 2016
Last Verified: May 2016