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NCT00064402 · ClinicalTrials.gov registry record · Phase 3

Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD

A Phase 3 study of Chronic Obstructive Pulmonary Disease and Emphysema, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 3
Development phase
741
Enrollment target
20
Study locations

NCT00064402 is a Phase 3 study of Chronic Obstructive Pulmonary Disease and Emphysema that has completed, run by Sumitomo Pharma America. The registered enrollment target is 741 participants, below the 1,745-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT00064402, a Phase 3 study of Chronic Obstructive Pulmonary Disease and Emphysema, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 3
Development phase
741 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD

Interventions

  • DRUG Placebo
  • DRUG Salmeterol
  • DRUG arformoterol tartrate inhalation solution

Study Locations (20)

California

  • Northern California Research Corp. - Fair Oaks
  • SARC Research Center - Fresno
  • California Research Medical Group, Inc. - Fullerton
  • Radiant Research-Irvine - Irvine
  • West Coast Clinical Trials - Newport Beach
  • Center for Clinical Trials, LLC - Paramount
  • Advances in Medicine - Rancho Mirage
  • Institute of Healthcare Assessment, Inc. - San Diego
  • San Jose Clinical Research - San Jose
  • Allergy & Asthma Medical Group of Diablo Valley, Inc. - Walnut Creek

Florida

  • Clinical Research of West Florida, Inc. - Clearwater
  • University Clinical Research, DeLand - DeLand
  • Mt. Sinai Medical Center - Miami Beach

Arizona

  • Pulmonary Associates, PA - Phoenix
  • Arizona Clinical Research Center, Inc. - Tucson

Colorado

  • Colorado Pulmonary Associates - Denver
  • Northern Colorado Pulmonary Consultants, PC - Fort Collins

Alabama

  • Pulmonary & Sleep Associates of Jasper, PC - Jasper

Connecticut

  • Physicians Research Center, Inc. - Hartford

District of Columbia

  • Washington Hospital Center - Washington D.C.

Trial Details

FieldValue
Enrollment Target 741 participants
Start Date 2002-04
Est. Completion 2004-03
Phase Phase 3

Sponsor

Sumitomo Pharma America

168 total trials

What the Registry Record Tells You About NCT00064402

The ClinicalTrials.gov registry entry for NCT00064402 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 741 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,745-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (58% lower). The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00064402 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT00064402 about?

NCT00064402 is a clinical study titled "Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD". The purpose of this study is to assess the bronchodilator effect and safety of multiple daily doses of arformoterol administered for 12 weeks as maintenance treatment in patients with COPD

What is the current status of trial NCT00064402?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 741 participants. The study started on 2002-04. Estimated completion is 2004-03.

What conditions does trial NCT00064402 study?

This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease, Emphysema, Chronic Bronchitis.

What interventions are being tested in trial NCT00064402?

The interventions under investigation include: Placebo (DRUG), Salmeterol (DRUG), arformoterol tartrate inhalation solution (DRUG).

Who is sponsoring clinical trial NCT00064402?

This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00064402 being conducted?

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

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.