PF-00489791 For The Treatment Of Raynaud's

Pfizer

Status and phase: Completed; Phase 2

Conditions: Peripheral Vascular Disease; Raynaud's Disease

Treatments: Drug: PF-00489791

Study type: Interventional

Funder types: Industry

Identifiers

NCT01090492

A7331010

EudraCT 2010-019009-40

2010-019009-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 243 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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243 participants in 8 patient groups

Secondary Raynaud 4 mg dose (period 1)

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Secondary Raynaud 4 mg dose (period 2)

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Secondary Raynaud 20 mg dose (period 1)

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Secondary Raynaud 20 mg dose (period 2)

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Primary Raynaud 4 mg dose (period 1)

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Primary Raynaud 4 mg dose (period 2)

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Primary Raynaud 20 mg dose (period 1)

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Primary Raynaud 20 mg dose (period 2)

Experimental group

Treatment:

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791

Drug: PF-00489791