Clinical Trial: PF-00489791 For The Treatment Of Raynaud's

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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 Summary:
Sponsor: Pfizer

Current Primary Outcome: Change in the Raynaud's Condition Score during the fourth week of treatment from baseline, comparing active drug to placebo [ Time Frame: 28 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]
  • Improvements in Raynaud's pain score comparing active to placebo [ Time Frame: 28 days ]
  • Decrease ulcer burden in secondary Raynaud's Phenomenon patients by hastening healing or preventing new ulcer emergence [ Time Frame: 28 days ]
  • Plasma concentration of PF-00489791 and metabolites [ Time Frame: 28 days ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: March 18, 2010
Date Started: August 2010
Date Completion:
Last Updated: July 25, 2014
Last Verified: July 2014