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Trial record 41 of 69 for:    "Bipolar Disorder" | "Olanzapine"

Olanzapine Treatment of Patients With Bipolar I Disorder

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: NCT00510146
Recruitment Status : Completed
First Posted : August 1, 2007
Results First Posted : May 26, 2011
Last Update Posted : May 26, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE July 30, 2007
First Posted Date  ICMJE August 1, 2007
Results First Submitted Date  ICMJE February 15, 2011
Results First Posted Date  ICMJE May 26, 2011
Last Update Posted Date May 26, 2011
Study Start Date  ICMJE August 2007
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Original Primary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
Assess whether olanzapine is superior to placebo in patients with bipolar depression based on improvements in overall symptomatology, measured by the mean change in the MADRS total score from baseline to LOCF endpoint. [ Time Frame: 10 weeks (includes screening period of 2-28 days) ]
Change History Complete list of historical versions of study NCT00510146 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2011)
  • Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase) [ Time Frame: Endpoint (Week 6) ]
    Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
  • Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase) [ Time Frame: Baseline through Endpoint (Week 6) ]
    Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
  • Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
    CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The score ranges from 1 (normal, not ill) to 7 (very seriously ill).
  • Percentage of Participants With Recovery (Acute Phase) [ Time Frame: Baseline through Endpoint (Week 6 ) ]
    Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
  • Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
    The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
  • Change From Baseline to Endpoint in Hamilton Depression Rating Scale-17 (HAMD-17) Total Score (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
    The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
  • Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase) [ Time Frame: Endpoint (Week 6) ]
    In the MINI Major Depressive Episode module, participants are asked a series of Yes/No questions to determine whether or not they are experiencing a major depressive episode or a major depressive episode with melancholic features.
  • Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase) [ Time Frame: Endpoint (Week 6) ]
    In the MINI Manic Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing hypomanic or manic episodes.
  • Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase) [ Time Frame: Endpoint (Week 6) ]
    In the MINI Psychotic Features Episode module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing mood disorder with psychotic features or current psychotic disorders.
  • Percentage of Participants With Alcohol Dependence and Abuse at Endpoint on MINI Alcohol Dependence/Abuse Module (Acute Phase) [ Time Frame: Endpoint (Week 6) ]
    In the MINI Alcohol Abuse and Dependence Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current alcohol dependence or abuse.
  • Percentage of Participants With Non-Alcohol Psychoactive Substance Use Disorder at Endpoint on MINI Substance Dependence/Abuse Module (Acute Phase) [ Time Frame: Endpoint (Week 6) ]
    In the MINI Substance Dependence and Abuse Module, participants are asked a series of Yes/No questions to determine whether or not they are currently experiencing symptoms indicating current non-alcohol substance use dependence or abuse.
  • Percentage of Participants With Emergence of Mania During the Study (Acute Phase) [ Time Frame: Baseline through Endpoint (Week 6) ]
    Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
  • Percentage of Participants With Extra-Pyramidal Symptoms (EPS) At Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Acute Phase) [ Time Frame: Endpoint (Week 6) ]
    EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score.
  • Change From Baseline to Endpoint in Blood Pressure (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change From Baseline to Endpoint in Weight (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change From Baseline to Endpoint in Albumin (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change From Baseline to Endpoint in Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT), Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT), Gamma Glutamyl Transferase (GGT) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change From Baseline to Endpoint in Direct Bilirubin, Total Bilirubin, Uric Acid (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change From Baseline to Endpoint in Erythrocyte Count (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change From Baseline to Endpoint in Hematocrit (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change From Baseline to Endpoint in Hemoglobin A1c (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change From Baseline to Endpoint in Hemoglobin (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change From Baseline to Endpoint in Prolactin (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change From Baseline to Endpoint in Urinalysis (UA)- Specific Gravity (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change in Electrocardiogram (ECG) From Baseline to Endpoint (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
    Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).
  • Change From Baseline to Endpoint in Heart Rate (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
  • Change From Baseline to Endpoint in MINI Suicidality Total Scores (Acute Phase) [ Time Frame: Baseline, Endpoint (Week 6) ]
    The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors.
  • Number of Participants With Adverse Events (Acute Phase) [ Time Frame: Baseline through Week 6 (Acute Phase) ]
    Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.
  • Percentage of Participants With Symptomatic Response in Montgomery-Asberg Depression Rating (MADRS) Depression Rating (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) ]
    The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Response is defined as a reduction (from baseline to endpoint) of 50% or more in the MADRS total score.
  • Percentage of Participants With Symptomatic Remission in the MADRS Total Score (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) ]
    Percentage of participants with symptomatic remission at any time as defined as a score of less than or equal to 12 in the MADRS total score. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
  • Percentage of Participants With Recovery (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) ]
    Percentage of participants with recovery defined as a value of less than or equal to 12 in the MADRS total score for at least 4 weeks of post-baseline treatment. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
  • Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
    The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
  • Percentage of Participants With Emergence of Mania During the Study (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) ]
    Emergence of mania is defined as first occurrence of score of >=15 in the YMRS total score in the Open-Label Extension. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
  • Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Open-Label Phase) [ Time Frame: Endpoint (Week 24) ]
    EPS symptoms measured by DIEPSS are grouped into 4 categories: parkinsonism, akathisia, dystonia, and dyskinesia. Severity is assessed at 5 levels, from level 0 (none, normal) to level 4 (severe). For Parkinsonism, normal baseline is defined as a score not >=3 on 1 item nor >=2 on 2 items; abnormal endpoint is defined as a score >=3 on 1 item or >=2 on 2 items, or an increase of 3 on Parkinsonism total. Baseline akathisia, dystonia and dyskinesia is defined as a score <2; abnormal endpoint is a score >=2 or an increase >= 2 from that baseline score.
  • Change From Baseline to Endpoint in Blood Pressure (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
  • Change From Baseline to Endpoint in Weight (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/ Week 6), Endpoint (Week 24) ]
  • Change From Baseline to Endpoint in Albumin and Total Protein (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
  • Change From Baseline to Endpoint in Alkaline Phosphatase, Creatinine Phosphokinase (CPK), GGT (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
  • Change From Baseline to Endpoint in Chloride (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
  • Change From Baseline to Endpoint in Creatinine (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
  • Change From Baseline to Endpoint in Erythrocyte Count (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
  • Change From Baseline to Endpoint in Hemoglobin (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
  • Change From Baseline to Endpoint in Platelet Count (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
  • Change From Baseline to Endpoint in Prolactin (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
  • Change From Baseline to Endpoint in Uric Acid (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
  • Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
  • Change From Baseline to Endpoint in ECG (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
    Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval); Bazett-Corrected QT Interval (QTcB interval).
  • Change From Baseline to Endpoint in Heart Rate (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6), Endpoint (Week 24) ]
  • Percentage of Participants With High Suicidality at Endpoint (Open-Label Phase) [ Time Frame: Endpoint (Week 24) ]
    The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (>=17).
  • Number of Participants With Adverse Events (Open-Label Phase) [ Time Frame: Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24) ]
    Please refer to the Adverse Event overview for details regarding adverse events and serious adverse events.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2007)
  • Assess olanzapine compared with placebo in terms of rate of response. [ Time Frame: 24 weeks (includes treatment & extension phase) ]
  • Assess olanzapine compared with placebo in terms of remission of depression & recovery. [ Time Frame: 24 weeks (includes treatment & extension phase) ]
  • Assess olanzapine compared with placebo in terms of improvement in clinical symptomatology. [ Time Frame: 24 weeks (includes treatment & extension phase) ]
  • Assess olanzapine compared with placebo in terms of emergence of mania. [ Time Frame: 24 weeks (includes treatment & extension phase) ]
  • Assess olanzapine compared with placebo in terms of incidence/severity of EPS. [ Time Frame: 24 weeks (includes treatment & extension phase) ]
  • Assess olanzapine compared with placebo in terms of rate of safety. [ Time Frame: 24 weeks (includes treatment & extension phase) ]
  • Assess olanzapine compared with placebo in terms of suicidality or serious suicidal risk. [ Time Frame: 24 weeks (includes treatment & extension phase) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Olanzapine Treatment of Patients With Bipolar I Disorder
Official Title  ICMJE Efficacy and Safety of Olanzapine in the Treatment of Patients With Bipolar I Disorder, Depressed: A Randomized, Double-Blind Comparison With Placebo
Brief Summary The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.
Detailed Description
  1. Dose range and administration mode: Oral Olanzapine 5mg - 20mg/day
  2. Duration:

    1. Screening phase is 2-28 days.
    2. Double-blind treatment phase is 6 weeks
    3. Open-label extension phase is 18 weeks
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression, Bipolar
Intervention  ICMJE
  • Drug: Olanzapine
    5-20 mg, oral, once daily, for 24 weeks (participants randomized to olanzapine in double-blind treatment period) or 18 weeks (participants randomized to placebo in double-blind treatment period).
    Other Names:
    • LY170053
    • Zyprexa
  • Drug: Placebo
    placebo tablets, oral, once daily at bedtime, 6 weeks
Study Arms  ICMJE
  • Experimental: Olanzapine
    During double-blind treatment, participants receive olanzapine at a dose of 5 milligram (mg) which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
    Intervention: Drug: Olanzapine
  • Placebo Comparator: Placebo
    Matching placebo administered once daily, by mouth during double-blind treatment.
    Intervention: Drug: Placebo
  • Experimental: Olanzapine (open-label treatment period)
    During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and Week 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
    Intervention: Drug: Olanzapine
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: April 26, 2011)
514
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2007)
510
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent
  • All female patients must test negative for pregnancy and females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug
  • Patients must fulfill the criteria for a major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) as well as criteria for bipolar I disorder, depressed, as defined in the DSM-IV-TR, based on clinical assessment and confirmed by the structured diagnostic interview, the Mini International Neuropsychiatric Interview (MINI), at study entry
  • Patients must have a current 17-item Hamilton Depression Rating Scale (HAMD-17) score greater than or equal to 18 at Visit 1 and Visit 2
  • Patients must have a current Young Mania Rating Scale (YMRS) total score less than or equal to 8 at Visit 2.

Exclusion Criteria:

  • Has received treatment within the past 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry
  • Has participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) before study entry
  • Was previously treated with olanzapine and had bipolar depression considered to be treatment-resistant to olanzapine or to olanzapine in combination with an available selective serotonin reuptake inhibitor (SSRI)
  • Is experiencing (at the time of study entry) a current episode of bipolar depression that is greater than 90 days in duration
  • Has been treatment-resistant to any therapy prescribed for bipolar depression when olanzapine alone or with an SSRI prescribed at an appropriate dose and duration
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Japan,   Korea, Republic of
Removed Location Countries Puerto Rico,   Taiwan,   United States
 
Administrative Information
NCT Number  ICMJE NCT00510146
Other Study ID Numbers  ICMJE 11218
F1D-MC-HGMP ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5hrs, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date April 2011

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