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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
Results First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Raynaud's Disease
Peripheral Vascular Disease
Intervention: Drug: PF-00489791

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 243 participants were stratified into 2 cohorts (Primary Raynaud’s phenomenon[PRP] and secondary RP[SRP]), who entered a 2-week placebo run-in period (to establish baseline), followed by a cross-over period (first 4 week treatment period,then a 2 week placebo washout,then 4 week treatment period) and then a 2-week placebo run-out period.

Reporting Groups
  Description
PRP Cohort: Placebo First, Then PF-00489791 4 mg Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
PRP Cohort: PF-00489791 4mg First, Then Placebo PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
PRP Cohort: Placebo First, Then PF-00489791 20 mg Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
PRP Cohort: PF-00489791 20 mg First, Then Placebo PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
SRP Cohort: Placebo First, Then PF-00489791 4 mg Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
SRP Cohort: PF-00489791 4 mg First, Then Placebo PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
SRP Cohort: Placebo First, Then PF-00489791 20 mg Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
SRP Cohort: PF-00489791 20 mg First, Then Placebo PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.

Participant Flow for 3 periods

Period 1:   First Intervention Period (4 Weeks)
    PRP Cohort: Placebo First, Then PF-00489791 4 mg   PRP Cohort: PF-00489791 4mg First, Then Placebo   PRP Cohort: Placebo First, Then PF-00489791 20 mg   PRP Cohort: PF-00489791 20 mg First, Then Placebo   SRP Cohort: Placebo First, Then PF-00489791 4 mg   SRP Cohort: PF-00489791 4 mg First, Then Placebo   SRP Cohort: Placebo First, Then PF-00489791 20 mg   SRP Cohort: PF-00489791 20 mg First, Then Placebo
STARTED   27   29   29   28   33   32   32   33 
COMPLETED   26   24   26   22   29   30   31   27 
NOT COMPLETED   1   5   3   6   4   2   1   6 
Protocol Violation                1                1                1                2                0                0                1                0 
Did not meet inclusion criteria                0                2                0                0                0                0                0                1 
Lost to Follow-up                0                0                1                0                0                0                0                0 
Other                0                0                1                1                2                0                0                0 
Pregnancy                0                0                0                0                1                0                0                0 
Adverse Event                0                2                0                3                1                2                0                5 

Period 2:   Placebo Washout Period ( 2 Weeks)
    PRP Cohort: Placebo First, Then PF-00489791 4 mg   PRP Cohort: PF-00489791 4mg First, Then Placebo   PRP Cohort: Placebo First, Then PF-00489791 20 mg   PRP Cohort: PF-00489791 20 mg First, Then Placebo   SRP Cohort: Placebo First, Then PF-00489791 4 mg   SRP Cohort: PF-00489791 4 mg First, Then Placebo   SRP Cohort: Placebo First, Then PF-00489791 20 mg   SRP Cohort: PF-00489791 20 mg First, Then Placebo
STARTED   26   24   26   22   29   30   31   27 
COMPLETED   26   24   26   22   29   30   31   27 
NOT COMPLETED   0   0   0   0   0   0   0   0 

Period 3:   Second Intervention Period (4 Weeks)
    PRP Cohort: Placebo First, Then PF-00489791 4 mg   PRP Cohort: PF-00489791 4mg First, Then Placebo   PRP Cohort: Placebo First, Then PF-00489791 20 mg   PRP Cohort: PF-00489791 20 mg First, Then Placebo   SRP Cohort: Placebo First, Then PF-00489791 4 mg   SRP Cohort: PF-00489791 4 mg First, Then Placebo   SRP Cohort: Placebo First, Then PF-00489791 20 mg   SRP Cohort: PF-00489791 20 mg First, Then Placebo
STARTED   26   24   26   22   29   30   31   27 
COMPLETED   25   22   24   22   27   29   22   25 
NOT COMPLETED   1   2   2   0   2   1   9   2 
Protocol Violation                1                0                0                0                1                0                1                1 
Non-compliance                0                1                0                0                0                0                0                0 
Other                0                1                1                0                0                0                0                0 
Adverse Event                0                0                1                0                1                1                7                1 
Lost to Follow-up                0                0                0                0                0                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PRP Cohort: Placebo First, Then PF-00489791 4 mg Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
PRP Cohort: PF-00489791 4mg First, Then Placebo PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention DB period and 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second DB intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
PRP Cohort: Placebo First, Then PF-00489791 20 mg Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second DB intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
PRP Cohort: PF-00489791 20 mg First, Then Placebo PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
SRP Cohort: Placebo First, Then PF-00489791 4 mg Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
SRP Cohort: PF-00489791 4 mg First, Then Placebo PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
SRP Cohort: Placebo First, Then PF-00489791 20 mg Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
SRP Cohort: PF-00489791 20 mg First, Then Placebo PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
Total Total of all reporting groups

Baseline Measures
   PRP Cohort: Placebo First, Then PF-00489791 4 mg   PRP Cohort: PF-00489791 4mg First, Then Placebo   PRP Cohort: Placebo First, Then PF-00489791 20 mg   PRP Cohort: PF-00489791 20 mg First, Then Placebo   SRP Cohort: Placebo First, Then PF-00489791 4 mg   SRP Cohort: PF-00489791 4 mg First, Then Placebo   SRP Cohort: Placebo First, Then PF-00489791 20 mg   SRP Cohort: PF-00489791 20 mg First, Then Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   29   29   28   33   32   32   33   243 
Age, Customized 
[Units: Participants]
Count of Participants
                 
Between 18 to 44 years      14  51.9%      12  41.4%      14  48.3%      14  50.0%      10  30.3%      6  18.8%      16  50.0%      9  27.3%      95  39.1% 
Between 45 to 64 years      13  48.1%      16  55.2%      15  51.7%      14  50.0%      22  66.7%      26  81.3%      16  50.0%      24  72.7%      146  60.1% 
Greater than or equal to (>=) 65 years      0   0.0%      1   3.4%      0   0.0%      0   0.0%      1   3.0%      0   0.0%      0   0.0%      0   0.0%      2   0.8% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                 
Female      25  92.6%      25  86.2%      25  86.2%      26  92.9%      30  90.9%      30  93.8%      31  96.9%      28  84.8%      220  90.5% 
Male      2   7.4%      4  13.8%      4  13.8%      2   7.1%      3   9.1%      2   6.3%      1   3.1%      5  15.2%      23   9.5% 


  Outcome Measures

1.  Primary:   Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4   [ Time Frame: Baseline, Week 4 ]

2.  Secondary:   Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4   [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4 ]

3.  Secondary:   Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4   [ Time Frame: Baseline, Week 4 ]

4.  Secondary:   Change From Baseline in the Mean Raynaud’s Pain Score at Week 1, 2, 3 and 4   [ Time Frame: Baseline, Week 1, 2, 3, 4 ]

5.  Secondary:   Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud’s Phenomenon Cohort   [ Time Frame: Baseline, Day 14, 28 ]

6.  Secondary:   Plasma Concentration of PF-00489791 and Its Metabolites   [ Time Frame: Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period) ]

7.  Secondary:   Number of Participants With Laboratory Test Abnormalities   [ Time Frame: Screening up to 28 days after last study dose (up to 98 days) ]

8.  Secondary:   Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements   [ Time Frame: Screening up to 28 days after last study dose (up to 98 days) ]

9.  Secondary:   Number of Participants With Abnormal Electrocardiogram (ECG) Values   [ Time Frame: Screening up to 28 days after last study dose (up to 98 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Plasma concentration of PF-00489791 metabolites was not intended as secondary endpoint in the protocol and was considered as an exploratory endpoint.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01090492     History of Changes
Other Study ID Numbers: A7331010
EudraCT 2010-019009-40
2010-019009-40 ( EudraCT Number )
First Submitted: March 18, 2010
First Posted: March 22, 2010
Results First Submitted: August 15, 2017
Results First Posted: May 16, 2018
Last Update Posted: May 16, 2018