CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 243 enrolled
Drug / intervention
PF-00489791 +7 moredrug
Likely dose
PF-00489791 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01090492
NCT01090492Phase 2Completed
CompareCT.gov

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

Pfizer·interventional·Posted Mar 22, 2010·Updated May 16, 2018

In Brief

A Phase 2 clinical trial evaluating PF-00489791 for Raynaud's Disease and Peripheral Vascular Disease. Completed, enrolled 243 participants across 55 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRaynaud's Disease, Peripheral Vascular Disease
CountriesCanada, Colombia, Czechia, Germany, Hungary, Mexico, Poland, South Korea, Spain, Sweden, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2010
Enrollment StartAug 4, 2010
Primary CompletionMay 31, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.3 years ago

Interventions

PF-00489791drug

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

PF-00489791drug

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

PF-00489791drug

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

PF-00489791drug

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

PF-00489791drug

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

PF-00489791drug

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

PF-00489791drug

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

PF-00489791drug

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