A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT00219622

Last Updated: 2012-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-07-31

Brief Summary

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This an initial proof of concept, phase to study to assess the safety and efficacy of tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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tofimilast

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Moderate-severe COPD (GOLD 2003 definition)
* Smoking history of at least 10 pack-years

Exclusion Criteria

* Any significant co-morbid disease, particularly cardiovascular
* Use of any maintenance therapy except short acting bronchodilators
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

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Riverside, California, United States

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Clearwater, Florida, United States

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Clearwater, Florida, United States

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Riverdale, Georgia, United States

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Stockbridge, Georgia, United States

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Normal, Illinois, United States

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Iowa City, Iowa, United States

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Madisonville, Kentucky, United States

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Wheaton, Maryland, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Buffalo, New York, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Lake Oswego, Oregon, United States

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Lincoln, Rhode Island, United States

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Spartanburg, South Carolina, United States

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Spartanburg, South Carolina, United States

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Dallas, Texas, United States

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Bellingham, Washington, United States

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Renton, Washington, United States

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Tukwila, Washington, United States

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La Plata, Buenos Aires, Argentina

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Vicente López, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Providencia, Santiago Metropolitan, Chile

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Recoleta, Santiago Metropolitan, Chile

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Santiago, , Chile

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ValparaÃ-so, , Chile

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San José, Provincia de San José, Costa Rica

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México, D.f., Mexico

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Monterrey, Nuevo León, Mexico

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Monterrey, Nuevo León, Mexico

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Countries

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United States Argentina Brazil Chile Costa Rica Mexico

Related Links

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Other Identifiers

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A2641022

Identifier Type: -

Identifier Source: org_study_id