Trial Profile
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate the Safety and Efficacy of Delamanid (OPC-67683) Administered Orally as 200 mg Total Daily Dose for Six Months in Patients With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 07 Nov 2021
Price :
$35
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At a glance
- Drugs Delamanid (Primary)
- Indications Tuberculosis
- Focus Registrational; Therapeutic Use
- Sponsors Otsuka Pharmaceutical; Otsuka Pharmaceutical Development & Commercialization
- 26 Oct 2020 Results (N=744) of a population pharmacokinetic analysis of data pooled from three phase II trials (Trials 204, 208 and 210) and one phase III trial (213) published in the Antimicrobial Agents and Chemotherapy
- 09 Jan 2017 Status changed from active, no longer recruiting to completed.
- 07 Aug 2016 This trial is completed in Estonia (end date:6 Jun 2016).