A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis
NCT01732211
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- Diagnosis of biopsy-proved chronic pulmonary sarcoidosis either Stage 2 or Stage 3 for at least 1 year;
- Forced Vital Capacity (FVC) lung assessment of >40% and < or = to 80% predicted normal values at screening;
- age 21-75 years of age;
- treatment with a stable (longer than 4 weeks) regimen of corticosteroids (between 10 and 30 mg of prednisone) for at least 3 months prior to Screening; (other anti-inflammatory drugs may be permitted as defined by the study protocol)
- History of any other pulmonary (lung) disease than sarcoidosis (ex, asthma requiring
maintenance treatment, chronic obstructive pulmonary disease (COPD));
- Pulmonary hypertension, significant lung fibrosis, any chronic infection (eg, TB,
HIV);
- treatment with other biologic anti-inflammatory/immuno-modulatory drugs;
- active smokers;
- class 3 or 4 congestive heart failure;
- cancer, or history of cancer within past 5 years;
- history of ischemic heart disease, heart attack, stroke, any heart muscle disease;
- liver disease;
- history of alcohol or drug abuse
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Descriptive Information | |||||||
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Brief Title ICMJE | A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis | ||||||
Official Title ICMJE | A PHASE 2 RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, 20-WEEK SAFETY, TOLERABILITY, AND EFFICACY STUDY OF PD 0360324 IN ADULT SUBJECTS WITH CHRONIC PULMONARY SARCOIDOSIS | ||||||
Brief Summary | The study proposes to evaluate the safety, tolerability, and efficacy of PD 0360324 in subjects with chronic pulmonary sarcoidosis inadequately treated with standard of care therapies. | ||||||
Detailed Description | The trial was terminated prematurely on Mar 24, 2014 due to a business decision. The decision to terminate the trial was not based on any clinical safety or efficacy concerns. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Basic Science | ||||||
Condition ICMJE | Pulmonary Sarcoidosis | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE | 1 | ||||||
Original Estimated Enrollment ICMJE | 120 | ||||||
Actual Study Completion Date ICMJE | September 23, 2013 | ||||||
Actual Primary Completion Date | September 23, 2013 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01732211 | ||||||
Other Study ID Numbers ICMJE | A6261009 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | December 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |