NCT01090492.

Trial name or title	A phase 2a randomised double‐blinded, placebo and active controlled two cohort two doses cross‐over multi‐centre 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.
Methods	Randomized double blind cross‐over trial
Participants	Ages eligible for study: 18 years to 65 years Genders eligible for study: Both Accepts healthy volunteers: No 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 three 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 four months •Participation in trial for investigational drug within 30 days
Interventions	Experimental: Secondary Raynaud 4 mg dose (period 1)  Drug: PF‐00489791 Subjects with Secondary Raynaud's Phenomenon will receive PF‐00489791 4 mg once a day for the first four week cross‐over period and then placebo once a day for the second four week cross‐over period Experimental: Secondary Raynaud 4 mg dose (period 2)  Drug: PF‐00489791 Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first four week cross‐over period and then PF‐00489791 4 mg once a day for the second four week cross‐over period Experimental: Secondary Raynaud 20 mg dose (period 1)  Drug: PF‐00489791 Subjects with Secondary Raynaud's Phenomenon will receive PF‐00489791 20 mg once a day for the first four week cross‐over period and then placebo once a day for the second four week cross‐over period Experimental: Secondary Raynaud 20 mg dose (period 2)  Drug: PF‐00489791 Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first four week cross‐over period and then PF‐00489791 20 mg once a day for the second four week cross‐over period Experimental: Primary Raynaud 4 mg dose (period 1)  Drug: PF‐00489791 Subjects with Primary Raynaud's Phenomenon will receive PF‐00489791 4 mg once a day for the first four week cross‐over period and then placebo once a day for the second four week cross‐over period Experimental: Primary Raynaud 4 mg dose (period 2)  Drug: PF‐00489791 Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first four week cross‐over period and then PF‐00489791 4 mg once a day for the second four week cross‐over period Experimental: Primary Raynaud 20 mg dose (period 1)  Drug: PF‐00489791 Subjects with Primary Raynaud's Phenomenon will receive PF‐00489791 20 mg once a day for the first four week cross‐over period and then placebo once a day for the second four week cross‐over period Experimental: Primary Raynaud 20 mg dose (period 2)  Drug: PF‐00489791 Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first four week cross‐over period and then PF‐00489791 20 mg once a day for the second four week cross‐over period
Outcomes	Primary outcome measures: •Change in the Raynaud's Condition Score during the fourth week of treatment from baseline, comparing active drug to placebo (Time frame: 28 days)   Secondary outcome measures: •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)
Starting date	Study start date: August 2010 Study completion date: May 2011 Primary completion date: May 2011 (Final data collection date for primary outcome measure)
Contact information	Pfizer CT.gov
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