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Клинические исследования в Украине

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Описание
Краткое названиеA Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
Полное названиеA 12-week, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multinational, Phase IIb Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at 3 Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
СпонсорAstraZeneca
Industry
ИсточникAstraZeneca
Под контролемAustralia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Japan: Ministry of Health, Labor and Welfare
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health and Social Development of the Russian Federation
Slovakia: State Institute for Drug Control
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Ukraine: State Pharmacological Center - Ministry of Health
United States: Food and Drug Administration
Yes
Краткое описаниеThe primary objective is to evaluate the dose-response relationship and efficacy of AZD9668
at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on
lung function and symptoms of COPD.
СостояниеЗавершено
Дата началаJuly 2009
ФазаPhase 2
Вид исследованияAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Набор0
КритерииInclusion Criteria:

- Diagnosis of COPD with symptoms over 1 year

- Smokers or ex-smokers

- Males or post-menopausal females between 40 and 80 years old

- Able to use electronic devices

Exclusion Criteria:

- Past history or current evidence of clinically significant heart disease

- Current diagnosis of asthma

- Patients who require long term oxygen therapy

- Treatment with antibiotics within 4 weeks of study visit 1b
ПолBoth
Минимальный возраст40 Years
Максимальный возраст80 Years
УсловиеChronic Obstructive Pulmonary Disease
Применяемое лечение
DrugAZD9668
DrugAZD9668
DrugAZD9668
DrugAZD9668 Placebo
Контакты и расположение
Dnipropetrovsk Research Site
Ivano-frankivsk Research Site
Kharkiv Research Site
Kyiv Research Site
Lugansk Research Site
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