TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)
NCT ID: NCT00413205
Last Updated: 2016-11-02
Study Results
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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COMPLETED
PHASE2
491 participants
INTERVENTIONAL
2007-01-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
po daily
Placebo
po daily
RAR Gamma
5mg po daily
RAR Gamma
5mg po daily
Interventions
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Placebo
po daily
RAR Gamma
5mg po daily
Eligibility Criteria
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Inclusion Criteria
* women not of child-bearing potential;
* ex-smokers (must have stopped smoking for \>=12 months) with clinical diagnosis of emphysema;
* willing to be switched to optimal COPD therapy.
Exclusion Criteria
* \>2 exacerbations of pulmonary symptoms requiring outpatient treatment, or \>1 exacerbation requiring hospitalization, within 12 months prior to screening;
* exposure to synthetic oral retinoids in past 12 months;
* history of allergy or sensitivity to retinoids.
44 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
San Diego, California, United States
Torrance, California, United States
Denver, Colorado, United States
Chicago, Illinois, United States
Detroit, Michigan, United States
Omaha, Nebraska, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Spartanburg, South Carolina, United States
Houston, Texas, United States
Pleven, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Brno, , Czechia
Karlovy Vary, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Balassagyarmat, , Hungary
Budapest, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Szombathely, , Hungary
Törökbálint, , Hungary
Reykjavik, , Iceland
Ashkelon, , Israel
Haifa, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Modena, Emilia-Romagna, Italy
Genoa, Liguria, Italy
Pavia, Lombardy, Italy
Pisa, Tuscany, Italy
Daugavpils, , Latvia
Riga, , Latvia
Riga, , Latvia
Riga, , Latvia
Bialystok, , Poland
Katowice, , Poland
Lodz, , Poland
Poznan, , Poland
Poznan, , Poland
Warsaw, , Poland
Warsaw, , Poland
Bellville, , South Africa
Bloemfontein, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Centurion, , South Africa
Durban, , South Africa
eManzimtoti, , South Africa
Johannesburg, , South Africa
Worcester, , South Africa
Donetsk, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Coventry, , United Kingdom
Liverpool, , United Kingdom
Countries
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Other Identifiers
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NB19751
Identifier Type: -
Identifier Source: org_study_id