Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

AMPLIFY - D6571C00001 Duaklir USA Phase III Study

NCT02796677 · View on ClinicalTrials.gov ↗

Study 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).

Interventions

  • DRUG Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg)
  • DRUG Aclidinium bromide 400 μg (AB 400 μg)
  • DRUG Formoterol fumarate 12 μg (FF 12 μg)
  • OTHER Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg
  • DRUG Tiotropium 18 μg (TIO 18 μg)

Study Locations (20)

Florida

  • Research Site — Clearwater
  • Research Site — Edgewater
  • Research Site — Hollywood
  • Research Site — Homestead
  • Research Site — Miami
  • Research Site — Miami
  • Research Site — Miami Lakes
  • Research Site — Ormond Beach
  • Research Site — Port Orange
  • Research Site — Sarasota
  • Research Site — St. Petersburg

California

  • Research Site — Corona
  • Research Site — Fresno
  • Research Site — Fullerton
  • Research Site — Lincoln
  • Research Site — San Diego

Arizona

  • Research Site — Phoenix
  • Research Site — Tucson

Alabama

  • Research Site — Gulf Shores

Connecticut

  • Research Site — Waterbury

Trial Details

FieldValue
Enrollment Target 1,595 participants
Start Date 2016-07-05
Est. Completion 2017-06-08
Phase Phase 3

Sponsor

AstraZeneca

1,053 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02796677

The ClinicalTrials.gov registry entry for NCT02796677 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,595 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 5 interventions — of which Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02796677 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02796677 about?

NCT02796677 is a clinical study titled "AMPLIFY - D6571C00001 Duaklir USA Phase III Study". 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 t...

What is the current status of trial NCT02796677?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,595 participants. The study started on 2016-07-05. Estimated completion is 2017-06-08.

What conditions does trial NCT02796677 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02796677?

The interventions under investigation include: Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg) (DRUG), Aclidinium bromide 400 μg (AB 400 μg) (DRUG), Formoterol fumarate 12 μg (FF 12 μg) (DRUG), Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg (OTHER), Tiotropium 18 μg (TIO 18 μg) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02796677?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02796677 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial