PF-00489791 For The Treatment Of Raynaud's

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01090492
First received: March 18, 2010
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Raynaud's Disease
Peripheral Vascular Disease
Drug: PF-00489791
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Improvements in Raynaud's pain score comparing active to placebo [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Decrease ulcer burden in secondary Raynaud's Phenomenon patients by hastening healing or preventing new ulcer emergence [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Plasma concentration of PF-00489791 and metabolites [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 243
Study Start Date: August 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned 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 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090492

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01090492     History of Changes
Other Study ID Numbers: A7331010, EudraCT 2010-019009-40
Study First Received: March 18, 2010
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 18, 2014