Клинические исследования в Украине

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Исследования / № 00413205

Краткое названиеTESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)
Полное названиеA Double-blind, Placebo-controlled Efficacy (as Assessed by Post-bronchodilator FEV1) and Safety Study of RAR Gamma in Subjects With Smoking-related, Moderate to Severe COPD With Emphysema Receiving Concurrent Optimised COPD Drug Therapy.
СпонсорHoffmann-La Roche
ИсточникHoffmann-La Roche
Под контролемUnited States: Food and Drug Administration
Краткое описаниеThis 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus
placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy.
Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to
receive either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in
addition to their standard therapy. Following the double-blind treatment period, patients
will enter a 4-week follow-up period. The anticipated time on study period is 1-2 years, and
the target sample size is 100-500 individuals.
ФазаPhase 2
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
КритерииInclusion Criteria:

- patients of >44 years of age, with >10 pack-year smoking history;

- women not of child-bearing potential;

- ex-smokers (must have stopped smoking for >=12 months) with clinical diagnosis of

- willing to be switched to optimal COPD therapy.

Exclusion Criteria:

- off oral steroids >28 days prior to enrollment;

- >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.
Минимальный возраст44 Years
Максимальный возрастN/A
Применяемое лечение
DrugRAR Gamma
Контакты и расположение
Donetsk , 83099
Kiev , 03680
Kiev , 01133
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