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A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium

NCT00949975 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 838

Last updated 2012-08-03

Study results available
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Summary

The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.

Conditions

Interventions

DRUG

AZD9668

2 x 30 mg oral tablets twice daily (bid) for 12 weeks

DRUG

AZD9668

2 x 10 mg oral tablets twice daily (bid) for 12 weeks

DRUG

AZD9668

2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks

DRUG

AZD9668 Placebo

2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Claus Volgemeier, Dr. · Director der Klinik fur Innere Medizin mit Schwerpunkt Pneumologie-Universitatsklinikum GieBen und Marburg, D-35043 Marburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Japan
  • Philippines
  • Poland
  • Russia
  • Slovakia
  • South Korea
  • Taiwan
  • Ukraine

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 NCT00949975 on ClinicalTrials.gov