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Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide

NCT01543919 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2014-10-27

No results posted yet for this study

Summary

PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

PH-797804

0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

DRUG

PH-797804

1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

DRUG

PH-797804

3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

DRUG

PH-797804

6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

DRUG

PH-797804

10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

DRUG

Placebo

Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Japan
  • Poland
  • Slovakia
  • South Africa
  • Spain
  • Sweden
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT01543919 on ClinicalTrials.gov