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AMPLIFY - D6571C00001 Duaklir USA Phase III Study

NCT02796677 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1595

Last updated 2018-11-09

Study results available
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Summary

This is a multiple dose, randomized, parallel, double-blind, double-dummy, multicenter and multinational Phase III study to determine the efficacy and safety of Aclidinium bromide 400μg/Formoterol Fumarate (AB/FF) 12 μg compared to individual components and TIO (Tiotropium) 18 μg when administered to patients with stable chronic obstructive pulmonary disease (COPD).

Conditions

Interventions

DRUG

Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg)

Inhalation powder

DRUG

Aclidinium bromide 400 μg (AB 400 μg)

Inhalation powder

DRUG

Formoterol fumarate 12 μg (FF 12 μg)

Inhalation powder

OTHER

Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg

Inhalation powder

DRUG

Tiotropium 18 μg (TIO 18 μg)

Powder in capsules for oral inhalation

OTHER

Placebo to TIO 18 μg

Powder in capsules for oral inhalation

Sponsors & Collaborators

Principal Investigators

  • Sanjay Sethi · 3495 Bailey Ave , Buffalo NY14215, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-05
Primary Completion
2017-06-08
Completion
2017-06-08
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Germany
  • Hungary
  • Israel
  • Poland
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02796677 on ClinicalTrials.gov