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PF-00489791 For The Treatment Of Raynaud's

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ClinicalTrials.gov Identifier: NCT01090492
Recruitment Status : Completed
First Posted : March 22, 2010
Last Update Posted : July 30, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Raynaud's Disease Peripheral Vascular Disease Drug: PF-00489791 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 5 Inhibitor (PF-00489791) For The Treatment Of Vasospasm In Primary And Secondary Raynaud's Phenomen
Study Start Date : August 2010
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 4 week cross over period and then placebo once a day for the second 4 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 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 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 4 week cross over period and then placebo once a day for the second 4 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 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 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 4 week cross over period and then placebo once a day for the second 4 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 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 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 4 week cross over period and then placebo once a day for the second 4 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 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. Improvements in Raynaud's pain score comparing active to placebo [ Time Frame: 28 days ]
  4. Decrease ulcer burden in secondary Raynaud's Phenomenon patients by hastening healing or preventing new ulcer emergence [ Time Frame: 28 days ]
  5. Plasma concentration of PF-00489791 and metabolites [ Time Frame: 28 days ]
  6. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090492


  Show 53 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01090492     History of Changes
Other Study ID Numbers: A7331010
EudraCT 2010-019009-40
First Posted: March 22, 2010    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014

Keywords provided by Pfizer:
Raynaud's phenomenon
vasospasm
scleroderma
systemic sclerosis
CREST
phosphodiesterase inhibitor

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Raynaud Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action