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Sponsored by: |
Schering-Plough |
---|---|
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00441701 |
This is a two-part study conducted at multiple centers, in subjects with moderate to severe COPD. Part 1 of the study is a double-blind, placebo-controlled, randomized, rising-dose study consisting of four treatment groups enrolled in three cohorts. The duration of treatment, for each cohort, will be a 2-week run-in period, followed by a 12-week double-blind treatment period. Part 2 of the study will be a double-blind, placebo-controlled, randomized, parallel group study consisting of four treatment groups enrolled as one cohort. The duration of treatment will consist of a 2-week run-in period, followed by a 12-week double-blind treatment period.
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease |
Drug: Drug 1: SCH 527123 Drug: Drug 2: Placebo to match SCH 527123 Drug: Drug 3: SCH 527123 Drug: Drug 4: Placebo to match SCH 527123 Drug: Drug 5: SCH 527123 Drug: Drug 6: Placebo to match SCH 527123 Drug: Drug 7: SCH 527123 Drug: Drug 8: SCH 527123 Drug: Drug 9: SCH 527123 Drug: Drug 10: Placebo to match SCH 527123 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Dose-Ranging Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD |
Enrollment: | 100 |
Study Start Date: | December 2006 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: SCH 527123: Experimental
Cohort 1, 3 mg
|
Drug: Drug 1: SCH 527123
3 mg dose SCH 527123 (1 mg x3 capsules) QD for 12 weeks
|
Arm 2: Placebo: Placebo Comparator
Cohort 1, placebo to match 3 mg-dose of SCH 527123
|
Drug: Drug 2: Placebo to match SCH 527123
3 capsules QD to match SCH 527123
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Arm 3: SCH 527123: Experimental
Cohort 2, 10 mg
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Drug: Drug 3: SCH 527123
10 mg capsule of SCH 527123 and 2 placebo capsules QD for 12 weeks
|
Arm 4: Placebo: Placebo Comparator
Cohort 2, placebo to match 10 mg-dose of SCH 527123
|
Drug: Drug 4: Placebo to match SCH 527123
3 placebo capsules QD to match SCH 527123
|
Arm 5: SCH 527123: Experimental
Cohort 3, 30 mg
|
Drug: Drug 5: SCH 527123
30 mg dose SCH 527123 (10 mg x3 capsules) QD for 12 weeks
|
Arm 6: Placebo: Placebo Comparator
Cohort 3, placebo to match 30 mg-dose of SCH 527123
|
Drug: Drug 6: Placebo to match SCH 527123
3 placebo capsules QD to match SCH 527123
|
Arm 7: SCH 527123: Experimental
Cohort 4, 3 mg
|
Drug: Drug 7: SCH 527123
3 mg dose SCH 527123 (1 mg x3 capsules) QD for 12 weeks
|
Arm 8: SCH 527123: Experimental
Cohort 4, 10 mg
|
Drug: Drug 8: SCH 527123
10 mg capsule of SCH 527123 and 2 placebo capsules QD for 12 weeks
|
Arm 9: SCH 527123: Experimental
Cohort 4, 30 mg
|
Drug: Drug 9: SCH 527123
30 mg dose SCH 527123 (10 mg x3 capsules) QD for 12 weeks
|
Arm 10: Placebo: Placebo Comparator
Cohort 4, placebo to match SCH 527123
|
Drug: Drug 10: Placebo to match SCH 527123
3 capsules QD to match SCH 527123
|
Ages Eligible for Study: | 41 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A female subject should be encouraged to continue using a highly effective method of birth control 30 days following the end of treatment.
A highly effective method of birth control is defined as that which results in a low failure rate (ie, less that 1% per year) when used consistently and correctly, such as hormonal implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUD).
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04592, SCH 525123, EUDRACT No.: 2005-004287-23 |
Study First Received: | February 28, 2007 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00441701 |
Health Authority: | Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |