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PF-00489791 For The Treatment Of Raynaud's

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NCT01090492

Last updated on November 28, 2019
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FOR MORE INFORMATION
Study Location
Stanford Hospital and Outpatient Center
Redwood City, California, 94063 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Raynaud's Disease, Peripheral Vascular Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01090492
Pfizer
Completed
PF-00489791 For The Treatment Of Raynaud's

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Descriptive Information
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 SummaryThe 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 DescriptionNot 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
  • Raynaud's Disease
  • Peripheral Vascular Disease
Intervention  ICMJE
  • Drug: PF-00489791
    Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period
  • Drug: PF-00489791
    Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period
  • Drug: PF-00489791
    Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period
  • Drug: PF-00489791
    Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period
  • Drug: PF-00489791
    Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period
  • Drug: PF-00489791
    Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period
  • Drug: PF-00489791
    Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period
  • Drug: PF-00489791
    Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period
Study Arms  ICMJE
  • Experimental: Secondary Raynaud 4 mg dose (period 1)
    Intervention: Drug: PF-00489791
  • Experimental: Secondary Raynaud 4 mg dose (period 2)
    Intervention: Drug: PF-00489791
  • Experimental: Secondary Raynaud 20 mg dose (period 1)
    Intervention: Drug: PF-00489791
  • Experimental: Secondary Raynaud 20 mg dose (period 2)
    Intervention: Drug: PF-00489791
  • Experimental: Primary Raynaud 4 mg dose (period 1)
    Intervention: Drug: PF-00489791
  • Experimental: Primary Raynaud 4 mg dose (period 2)
    Intervention: Drug: PF-00489791
  • Experimental: Primary Raynaud 20 mg dose (period 1)
    Intervention: Drug: PF-00489791
  • Experimental: Primary Raynaud 20 mg dose (period 2)
    Intervention: Drug: PF-00489791
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
 (submitted: July 25, 2014)		243
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2010)		208
Actual Study Completion Date  ICMJE May 31, 2011
Actual Primary Completion DateMay 31, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CountriesArgentina,   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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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