Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD

NCT ID: NCT00263874

Last Updated: 2007-07-23

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-09-30

Brief Summary

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This initial proof of concept, phase II study aims to assess the safety and efficacy of UK-500,001 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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UK-500,001

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Moderate-severe COPD (Global inititiative for chronic Obstructive Lung Disease, GOLD, 2003 definition)
* Smoking history of at least 10 pack-years

Exclusion Criteria

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

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

La Plata, Buenos Aires, Argentina

Site Status

Pfizer Investigational Site

Vicente López, Buenos Aires, Argentina

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Pfizer Investigational Site

Rosario, Santa Fé, Argentina

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Pfizer Investigational Site

Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Camperdown, New South Wales, Australia

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Clayton, Victoria, Australia

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Nedlands, Western Australia, Australia

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Calgary, Alberta, Canada

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Red Deer, Alberta, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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Santiago, RM, Chile

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Providencia, Santiago Metropolitan, Chile

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ValparaÃ-so, ValparaÃ-so, Chile

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Zagreb, , Croatia

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Olomouc, , Czechia

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Ostrava-Poruba, , Czechia

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Prague, , Czechia

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Tábor, , Czechia

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Debrecen, , Hungary

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Törökbálint, , Hungary

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Veszprém, , Hungary

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Singapore, , Singapore

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Singapore, , Singapore

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Pfizer Investigational Site

Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Pfizer Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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Argentina Australia Canada Chile Croatia Czechia Hungary Singapore Spain United Kingdom

References

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Vestbo J, Tan L, Atkinson G, Ward J; UK-500,001 Global Study Team. A controlled trial of 6-weeks' treatment with a novel inhaled phosphodiesterase type-4 inhibitor in COPD. Eur Respir J. 2009 May;33(5):1039-44. doi: 10.1183/09031936.00068908. Epub 2009 Feb 12.

Reference Type DERIVED
PMID: 19213793 (View on PubMed)

Related Links

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Other Identifiers

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A5641009

Identifier Type: -

Identifier Source: org_study_id