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A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01484561
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 30, 2011
First Posted Date  ICMJE December 2, 2011
Results First Submitted Date  ICMJE January 11, 2014
Results First Posted Date  ICMJE April 2, 2014
Last Update Posted Date April 2, 2014
Study Start Date  ICMJE April 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR) [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
Glomerular filtration rate (GFR) is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 meters squared (m^2) body surface area. A normal GFR is greater than (>)90 milliliters per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 mL/min is consistent with kidney failure. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
Change in measured glomerular filtration rate (as determined by iohexol serum clearance) at the end of Period 1 from baseline. [ Time Frame: End of Period 1, approximately Day 43 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
    mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.
  • Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]
    mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m^2 body surface area.
  • Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD) [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
    eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.
  • Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
    eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.
  • Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]
    eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area.
  • Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
    eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.
  • Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
    eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.
  • Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]
    eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area.
  • Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
    Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in milligrams per deciliter (mg/dL) reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.
  • Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
    Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.
  • Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]
    Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used.
  • Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response [ Time Frame: Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2 ]
    ACR20 response: greater than or equal to (≥)20 percent (%) improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
  • Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response [ Time Frame: Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2 ]
    ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.
  • Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response [ Time Frame: Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2 ]
    ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant' assessment of functional disability via a HAQ, and 5) CRP at each visit.
  • Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP]) [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
    DAS28 calculated from the tender/painful joint count, swollen joint count (SJC) using the 28 joints count, and CRP value. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
  • LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP) [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
    DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP) [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]
    DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP) [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
    DAS28 calculated from the number of SJC and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP) [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
    DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP) [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]
    DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
  • LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
    68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb interphalangeal [IP], PIP, and distal interphalangeals [DIP]), and lower extremity (hip, knee, ankle, tarsus, metatarsophalangeals [MTP], great toe IP, proximal and distal interphalangeals combined [PIP]).
  • LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
    68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).
  • LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]
    68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).
  • LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
    Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).
  • LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
    Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).
  • LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]
    Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).
  • LS Mean Change at End of Period 1 From Baseline in CRP [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
  • LS Mean Change at End of Period 2 From Baseline in CRP [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
  • LS Mean Change at End of Period 2 From End of Period 1 in CRP [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]
  • LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA) [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
    Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very well and 100 mm = very poorly.
  • LS Mean Change at End of Period 2 From Baseline in PGAA [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
    Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
  • LS Mean Change at End of Period 2 From End of Period 1 in PGAA [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]
    Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
  • LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
    A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.
  • LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
    A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.
  • LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis [ Time Frame: Day 43 of Period 1, Day 29 of Period 1 ]
    A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.
  • LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
    Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
  • LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
    Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
  • LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain [ Time Frame: Day 43 of Period 2, Day 29 of Period 2 ]
    Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
  • LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score [ Time Frame: Day 1 of Period 1, Day 43 of Period 1 ]
    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
  • LS Mean Change at End of Period 2 From Baseline HAQ-DI Score [ Time Frame: Day 1 of Period 1, Day 29 of Period 2 ]
    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
  • LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score [ Time Frame: Day 43 of Period 1, Day 29 of Period 2 ]
    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
  • Change in measured glomerular filtration rate (mGFR) at the end of Period 2 from baseline. [ Time Frame: End of Period 2, approximately Day 72 ]
  • Change in mGFR at the end of Period 2 from the end of Period 1. [ Time Frame: End of Period 2, approximately Day 29 ]
  • Change in estimated glomerular filtration rate (eGFR) from baseline to the end of Period 1. [ Time Frame: End of Period 1, approximately Day 43 ]
  • Change in eGFR from baseline to the end of Period 2. [ Time Frame: End of Period 2, approximately Day 72 ]
  • Change in serum creatinine from baseline to the end of Period 1. [ Time Frame: End of Period 1, approximately Day 43 ]
  • Change in serum creatinine from baseline to the end of Period 2. [ Time Frame: End of Period 2, approximately Day 72 ]
  • American College of Rheumatology (ACR) 20/50/70 and Disease Activity Score 28 joint count and using C-Reactive Protein (DAS28 [CRP]) at end of Period 1. [ Time Frame: End of Period 1, approximately Day 43 ]
  • ACR20/50/70 and DAS28 (CRP) at end of Period 2. [ Time Frame: End of Period 2, approximately Day 72 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis
Official Title  ICMJE A Phase 1, Randomized, Placebo-Controlled, Two-Period, Fixed Sequence Study To Evaluate The Effect Of CP-690,550 On Measured Glomerular Filtration Rate In Patients With Active Rheumatoid Arthritis
Brief Summary The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of kidney function in patients with active rheumatoid arthritis (RA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: CP-690,550 or Placebo
    CP-690,550 10 mg twice a day (BID) orally or placebo BID orally, approximately 72 days
  • Drug: Placebo
    Placebo BID orally, approximately 72 days
Study Arms  ICMJE
  • Active Comparator: Sequence 1
    Intervention: Drug: CP-690,550 or Placebo
  • Placebo Comparator: Sequence 2
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2014)
148
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2011)
132
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of rheumatoid arthritis by satisfying at least four of the seven criteria.
  • The patient must have active disease at both Screening and predose on Day 1 of Period 1.
  • Patient must have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD), non-biologic or biologic, due to ineffectiveness or intolerance.

Exclusion Criteria:

  • Pregnant or lactating women
  • Serious medical conditions that would make treatment with CP-690,550 potentially unsafe.
  • A patient who has a history of asthma, multiple allergies or severe allergy (eg, anaphylaxis) to any substance. In particular, a history of allergy to iodine, povidone-iodine, iohexol or other iodinated contrast media.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Germany,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01484561
Other Study ID Numbers  ICMJE A3921152
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP