In the multinational, randomized, Phase II double-blind placebo-controlled trial using ruboxistaurin (a PKC-β inhibitor) there was, however, no difference in the primary endpoint of change in vibration detection threshold (VDT).
The Bosutinib Efficacy and Safety in Newly Diagnosed Chronic Myeloid Leukemia (BELA) trial is an open-label, multinational, randomized phase 3 trial investigating the efficacy and safety of bosutinib as compared with imatinib in newly diagnosed chronic phase CML (CP CML) 19.
This was a multinational, randomized, double-blind, phase IV study in 60 patients; follow-up was 1 month.
This multinational, double-blind, randomized phase III study (NCT01376297) in 413 chemotherapy-naïve patients evaluated a single oral dose of NEPA (NETU 300 mg + PALO 0.50 mg) given on day 1 with oral dexamethasone (DEX).
This multinational, double-blind, randomized, phase 3 clinical trial demonstrated that IV tigecycline (100 mg initial dose, followed by 50 mg every 12 hours) is as effective as IV levofloxacin (500 mg once- or twice-daily) for the treatment of hospitalized adult patients with CAP.
The Prospective, Randomized Study of OXC XR in Subjects with Partial Epilepsy Refractory (PROSPER) study was a multinational, randomized, double-blind, parallel-group Phase 3 study.
101 The multicenter, multinational, double-blind, placebo-controlled, randomized, phase 3 trial was planned to evaluate 650 patients with metastatic sarcoma who have had favorable outcomes (eg, SD, PR, or CR) to first-line, second-line, or third-line chemotherapy.
RELAX-AHF-ASIA, a multinational, randomized, double-blind, placebo-controlled, phase III trial, will evaluate the effects of serelaxin on symptom relief and clinical outcomes in Asian AHF patients, with the use of novel assessments.
The approval was based on phase III multinational, randomized trial METRIC [ 56, 57].
35 The DUET-1 and DUET-2 are multinational, randomized, double-blind, placebo-controlled phase III trials with identical design and conducted in different areas of the world.
A phase 2, multinational, randomized, double-blind, active-controlled trial was conducted to evaluate the safety and efficacy of telavancin for the treatment of adult patients with uncomplicated SAB [ 38].
