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Trial record 1 of 1 for:    NCT00624780
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Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00624780
Recruitment Status : Completed
First Posted : February 27, 2008
Results First Posted : April 19, 2013
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 15, 2008
First Posted Date  ICMJE February 27, 2008
Results First Submitted Date  ICMJE March 5, 2013
Results First Posted Date  ICMJE April 19, 2013
Last Update Posted Date April 19, 2013
Study Start Date  ICMJE May 2009
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
  • Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 [ Time Frame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9) ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 [ Time Frame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 [ Time Frame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2 [ Time Frame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 [ Time Frame: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Change From Baseline in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2 [ Time Frame: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.
  • Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 [ Time Frame: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9) ]
    PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
  • Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 2 [ Time Frame: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) ]
    PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
  • Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 [ Time Frame: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) ]
    PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
  • Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 2 [ Time Frame: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) ]
    PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
  • Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 [ Time Frame: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) ]
    PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
  • Change From Last Visit on Treatment in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 2 [ Time Frame: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) ]
    PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2008)
  • Efficacy endpoints: Hamilton Anxiety Scale (HAM-A), Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement (CGI-I). [ Time Frame: 3 & 6 months ]
  • Safety endpoints: Adverse events at 3 and 6 months, Physicians Withdrawal Checklist (PWC), Rebound Anxiety (HAM-A), Discontinuation Emergent Signs and Symptoms (DESS) [ Time Frame: 3 and 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
  • Number of Participants With Rebound Anxiety for Cohort 1 (Less Than 3-Month Last Visit) [ Time Frame: 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9) ]
    Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.
  • Number of Participants With Rebound Anxiety for Cohort 2 (3-Month Last Visit) [ Time Frame: 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) ]
    Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.
  • Number of Participants With Rebound Anxiety for Cohort 3 (6-Month Last Visit) [ Time Frame: 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) ]
    Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value.
  • Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 1 (Less Than 3-Month Last Visit) [ Time Frame: 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9) ]
    DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.
  • Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 2 (3-Month Last Visit) [ Time Frame: 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) ]
    DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.
  • Number of Participants With Discontinuation-Emergent Signs and Symptoms (DESS) for Cohort 3 (6-Month Last Visit) [ Time Frame: 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) ]
    DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2.
  • Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2 [ Time Frame: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) ]
    PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
  • Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2 [ Time Frame: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) ]
    PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
  • Change From Baseline in Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2 [ Time Frame: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24) ]
    PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
  • Physician's Withdrawal Checklist (PWC) Score for Cohort 1 (Less Than 3-Month Last Visit) [ Time Frame: Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) ]
    PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
  • Physician's Withdrawal Checklist (PWC) Score for Cohort 2 (3-Month Last Visit) [ Time Frame: Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) ]
    PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
  • Physician's Withdrawal Checklist (PWC) Score for Cohort 3 (6-Month Last Visit) [ Time Frame: Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24) ]
    PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.
  • Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) at Discontinuation Week 1 and 2 [ Time Frame: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) at Discontinuation Week 1 and 2 [ Time Frame: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.
  • Change From Last Visit of Treatment in Hamilton Anxiety Scale (HAM-A) for Cohort 3 (6-Month Last Visit) at Discontinuation Week 1 and 2 [ Time Frame: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24) ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Hamilton Anxiety Scale (HAM-A) for Cohort 1 (Less Than 3-Month Last Visit) [ Time Frame: Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9) ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Hamilton Anxiety Scale (HAM-A) for Cohort 2 (3-Month Last Visit) [ Time Frame: Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15) ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected.
  • Hamilton Anxiety Scale (HAM-A) Score for Cohort 3 (6-Month Last Visit) [ Time Frame: Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24) ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Hamilton Anxiety Scale (HAM-A) Score for Period 1 [ Time Frame: Baseline, Week 12 ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Hamilton Anxiety Scale (HAM-A) Score for Period 2 [ Time Frame: Baseline, Week 24 ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 12 [ Time Frame: Baseline, Week 12 ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24 [ Time Frame: Baseline, Week 24 ]
    HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected.
  • Clinical Global Impression - Severity (CGI-S) Score for Period 1 [ Time Frame: Baseline, Week 12 ]
    CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
  • Clinical Global Impression - Severity (CGI-S) Score for Period 2 [ Time Frame: Baseline, Week 24 ]
    CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected
  • Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12 [ Time Frame: Baseline, Week 12 ]
    CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
  • Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24 [ Time Frame: Baseline, Week 24 ]
    CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected
  • Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 1 [ Time Frame: Week 12 ]
    CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
  • Clinical Global Impression - Improvement (CGI-I) Score at the End of Period 2 [ Time Frame: Week 24 ]
    CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2008)
Adverse events [ Time Frame: through study ]
Current Other Pre-specified Outcome Measures
 (submitted: March 5, 2013)
  • Sheehan-Suicidality Tracking Scale (S-STS) Score [ Time Frame: Baseline up to Week 24 ]
    Sheehan-Suicidality Tracking Scale (S-STS): an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2-6, 7a, and 8 were scored on a 5-point Likert scale (ranging from 0= not at all to 4=extremely). Items 1, 1b, and 7 required yes or no responses. Total score ranged from 0 to 35, higher score indicated higher suicidal tendency.
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) [ Time Frame: Baseline up to Week 12 (period 1), Week 13 up to Week 24 (period 2) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and Week 12, for period 1, and between Week 13 and Week 24, for period 2, that were absent before treatment or that worsened relative to pretreatment state.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
Official Title  ICMJE Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder
Brief Summary The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE
  • Drug: Pregabalin
    Pregabalin 150-300 mg given twice a day
    Other Name: Lyrica
  • Drug: Lorazepam
    Lorazepam 3-4 mg given twice a day
  • Drug: Pregabalin
    Pregabalin 450-600 mg given twice a day
    Other Name: Lyrica
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Pregabalin
  • Active Comparator: 2
    Intervention: Drug: Lorazepam
  • Experimental: 3
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Publications * Kasper S, Iglesias-García C, Schweizer E, Wilson J, DuBrava S, Prieto R, Pitman VW, Knapp L. Pregabalin long-term treatment and assessment of discontinuation in patients with generalized anxiety disorder. Int J Neuropsychopharmacol. 2014 May;17(5):685-95. doi: 10.1017/S1461145713001557. Epub 2013 Dec 19.

*   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: September 25, 2012)
615
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2008)
600
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis Generalized Anxiety Disorder
  • HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline
  • Needs pharmacological treatment

Exclusion Criteria:

  • Current or past diagnosis of any other DSM IV Axis I disorders
  • A history of failed treatment with a benzodiazepine
  • Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 Argentina,   Austria,   Costa Rica,   Croatia,   Czech Republic,   Finland,   Greece,   India,   Indonesia,   Lithuania,   Mexico,   Russian Federation,   Serbia,   Slovenia,   Spain,   Turkey
Removed Location Countries Colombia
 
Administrative Information
NCT Number  ICMJE NCT00624780
Other Study ID Numbers  ICMJE A0081147
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2012

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