Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)
This study has been completed.
Sponsor:
Takeda Global Research & Development Center, Inc.
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00073177
First received: November 17, 2003
Last updated: May 4, 2012
Last verified: January 2012
| Tracking Information | |||||
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| First Received Date ICMJE | November 17, 2003 | ||||
| Last Updated Date | May 4, 2012 | ||||
| Start Date ICMJE | November 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
change in lung function from baseline to final visit. | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00073177 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012) | ||||
| Official Title ICMJE | A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 Mcg or 500 Mcg) Daily in Patients With Asthma | ||||
| Brief Summary | The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Drug: Roflumilast | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 819 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Main Inclusion Criteria:
Main Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Argentina, Colombia, Mexico, Peru | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00073177 | ||||
| Other Study ID Numbers ICMJE | BY217/M2-012 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Takeda Global Research & Development Center, Inc. | ||||
| Study Sponsor ICMJE | Takeda Global Research & Development Center, Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Takeda Global Research & Development Center, Inc. | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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