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A Phase 3, Randomized, Double-blind, Double-dummy, Parallel-group, Active Drug and Placebo-controlled, Safety, Efficacy and Superiority of Sibutramine IR/Topiramate XR in Overweight Adults With Comorbidities/Obesity

Trial Profile

A Phase 3, Randomized, Double-blind, Double-dummy, Parallel-group, Active Drug and Placebo-controlled, Safety, Efficacy and Superiority of Sibutramine IR/Topiramate XR in Overweight Adults With Comorbidities/Obesity

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Feb 2025

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At a glance

  • Drugs Sibutramine/topiramate (Primary) ; Sibutramine; Topiramate
  • Indications Obesity
  • Focus Registrational; Therapeutic Use
  • Acronyms UNLIMITED
  • Sponsors Eurofarma
  • Most Recent Events

    • 14 Feb 2025 Planned End Date changed from 30 Jul 2027 to 1 Mar 2028.
    • 14 Feb 2025 Planned primary completion date changed from 30 Mar 2027 to 1 Mar 2028.
    • 14 Feb 2025 Planned initiation date changed from 30 Oct 2025 to 1 Apr 2026.

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