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Dose Finding Study in Patients With Mild to Moderate Persistent Asthma: A Parallel Group, Randomised, Placebo Controlled, Double Blind Assessment of Oral Oc000459 Dosed At Three Dose Schedules for Twelve Weeks Finding Study In Patients With Mild To Moderate Persistent Asthma
This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist drugs alone. This study will compare the patients on OC000459 at three different dose levels (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment arm will consist of at least 110 subjects. The objective is to assess the efficacy of these dose levels on the patients asthma.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
No
Research site
Sofia, Bulgaria
Research site
Győr, Hungary
Research site
Warsaw, Poland
Research site
Bucharest, Romania
Research site
Moscow, Russia
Research site
Kiev, Ukraine
Start Date
April 1, 2009
Primary Completion Date
May 1, 2010
Completion Date
July 1, 2010
Last Updated
September 2, 2010
480
ESTIMATED participants
OC000459 or placebo
DRUG
Lead Sponsor
Oxagen Ltd
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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