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| Sponsor: | Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00063869 |
Purpose
The objective of the study is to evaluate the safety and efficacy of etanercept in comparison with placebo in a double-blind, parallel, randomized fashion in subjects with idiopathic pulmonary fibrosis (IPF) who failed previous therapy. The treatment period will be up to 1 year. The primary objective is evaluation of safety and efficacy. Secondary: The secondary objective is to evaluate quality of life (QoL) and pharmacokinetics (PK).
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Fibrosis |
Drug: Etanercept |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-blind, Parallel, Placebo-controlled, Randomized Study of the Efficacy and Safety of Etanercept in Patients With Idiopathic Pulmonary Fibrosis. |
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | 0881A4-203 |
| Study First Received: | July 7, 2003 |
| Last Updated: | September 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00063869 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Idiopathic Pulmonary Fibrosis Fibrosis, Pulmonary Pulmonary Fibroses Fibroses, Pulmonary |
|
Anti-Inflammatory Agents Lung Diseases, Interstitial Immunologic Factors Fibrosis Physiological Effects of Drugs Gastrointestinal Agents TNFR-Fc fusion protein Immunosuppressive Agents Pulmonary Fibrosis Pharmacologic Actions Pathologic Processes |
Respiratory Tract Diseases Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Lung Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |