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PF-00489791 For The Treatment Of Raynaud's

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NCT01090492

Last updated on March 25, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
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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PF-00489791 For The Treatment Of Raynaud's
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 Phenomen
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Raynaud's Disease
  • Peripheral Vascular Disease
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
243
May 2011
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Colombia,   Czech Republic,   Germany,   Hungary,   Korea, Republic of,   Mexico,   Poland,   Spain,   Sweden,   United States
Argentina
 
NCT01090492
A7331010
EudraCT 2010-019009-40
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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