AMPLIFY - D6571C00001 Duaklir USA Phase III Study

Study identifier:D6571C00001

ClinicalTrials.gov identifier:NCT02796677

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 24 week treatment, multicenter, randomized, double blinded, double dummy, parallel-group, clinical trial evaluating the efficacy and safety of aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed-dose combination BID compared with each monotherapy (aclidinium bromide 400 μg BID and formoterol fumarate 12 μg BID) and tiotropium 18 μg QD when administered to patients with stable chronic obstructive pulmonary disease.

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 3

Healthy volunteers

No

Study drug

Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg), Aclidinium bromide 400 μg (AB 400 μg), Formoterol fumarate 12 μg (FF 12 μg), Tiotropium 18 μg (TIO 18 μg)

Sex

All

Actual Enrollment

1595

Study type

Interventional

Age

40 Years - 130 Years

Date

Study Start Date: 05 Jul 2016
Primary Completion Date: 08 Jun 2017
Study Completion Date: 08 Jun 2017

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria