ABOUT THIS STUDY
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- Active Raynaud's Phenomenon
- Stable disease and medication requirements over the previous two months
- For Secondary Raynaud's Phenomenon subjects, a diagnosis of scleroderma using the American College of Rheumatology criteria or by the presence of at least 3/5 features of CREST syndrome
- both sexes
- Uncontrolled hypertension, diabetes mellitus, angina, or using oral nitrates
- Smoking within 3 months or smoking cessation using nicotine products
- Subjects currently taking sildenafil, tadalafil or vardenafil
- Subjects with ulnar arterial occlusive disease as shown by a modified Allen test
- Pregnant or breast feeding or considering pregnancy in next 4 months
- Participation in trial for investigational drug within 30 days
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Descriptive Information | ||||
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Brief Title ICMJE | PF-00489791 For The Treatment Of Raynaud's | |||
Official Title ICMJE | A Phase 2a Randomized Double-blinded, Placebo And Active Controlled Two Cohort Two Doses Cross-over Multi-center Clinical Study To Assess Efficacy Of A Once Daily Administration Of A Phosphodiesterase 5 Inhibitor (Pf-00489791) For The Treatment Of Vasospasm In Primary And Secondary Raynaud's Phenomenon | |||
Brief Summary | The investigators propose that once daily administration of PF-00489791, a phosphodiesterase inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and Secondary Raynaud's Phenomenon. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE |
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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 | Completed | |||
Actual Enrollment ICMJE | 243 | |||
Original Estimated Enrollment ICMJE | 208 | |||
Actual Study Completion Date ICMJE | May 31, 2011 | |||
Actual Primary Completion Date | May 31, 2011 (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 | 18 Years to 65 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 | Canada, Colombia, Czechia, Germany, Hungary, Korea, Republic of, Mexico, Poland, Spain, Sweden, United States | |||
Removed Location Countries | Argentina, Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01090492 | |||
Other Study ID Numbers ICMJE | A7331010 EudraCT 2010-019009-40 2010-019009-40 ( EudraCT Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | April 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |