Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

PF-00489791 For The Treatment Of Raynaud's

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01090492
First received: March 18, 2010
Last updated: July 25, 2014
Last verified: July 2014

March 18, 2010
July 25, 2014
August 2010
May 2011   (final data collection date for primary outcome measure)
Change in the Raynaud's Condition Score during the fourth week of treatment from baseline, comparing active drug to placebo [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01090492 on ClinicalTrials.gov Archive Site
  • Change in the number of Raynaud's Phenomenon attacks per week during the fourth week of treatment compared to the number of Raynaud's Phenomenon attacks week at baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Change in the total duration of Raynaud's Phenomenon attacks per week during the fourth week of treatment compared to the total duration of Raynaud's Phenomenon attacks per week at baseline [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Improvements in Raynaud's pain score comparing active to placebo [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Decrease ulcer burden in secondary Raynaud's Phenomenon patients by hastening healing or preventing new ulcer emergence [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Plasma concentration of PF-00489791 and metabolites [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Safety and tolerability of PF-00489791 as assessed by incidences of treatment emergent adverse events and changes from baseline for clinical laboratory tests, vital signs, orthostatic blood pressure measurements and 12-lead ECG parameters [ Time Frame: 98 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Colombia,   Czech Republic,   Germany,   Hungary,   Korea, Republic of,   Mexico,   Poland,   Spain,   Sweden
 
NCT01090492
A7331010, EudraCT 2010-019009-40
No
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