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A Study of LY2216684 and Warfarin in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01263119
Recruitment Status : Completed
First Posted : December 20, 2010
Results First Posted : October 19, 2018
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Warfarin
Drug: LY2216684
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Warfarin, LY2216684 + Warfarin
Hide Arm/Group Description Period 1: Single 10-milligram (mg) warfarin oral dose on Day 1; Washout Period of at least 14 days; Period 2: 18-mg LY2216684 oral dose, once daily on Days 1 to 12, with single 10-mg warfarin oral dose coadministered on Day 3.
Period Title: Period 1
Started 18
Completed 16
Not Completed 2
Reason Not Completed
Protocol Violation             2
Period Title: Period 2
Started 16
Completed 14
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title Warfarin, LY2216684 + Warfarin
Hide Arm/Group Description Period 1: Single 10-milligram (mg) warfarin oral dose on Day 1; Washout Period of at least 14 days; Period 2: 18-mg LY2216684 oral dose, once daily on Days 1 to 12, with single 10-mg warfarin oral dose coadministered on Day 3.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
38.2  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
8
  44.4%
Male
10
  55.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Black or African American 6
Multiple 4
White 8
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of S-Warfarin
Hide Description Least Squares (LS) geometric mean was based on AUC0-∞ of S-warfarin; calculated when warfarin was administered alone (reference) on Day 1 of Period 1 and coadministered with LY2216684 (test) on Day 3 of Period 2.
Time Frame Pre-dose, 1, 2, 3, 4, 5, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-warfarin administration on Days 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who received at least 1 dose of warfarin and had evaluable concentration data.
Arm/Group Title 10 mg Warfarin + 18 mg LY2216684 (Test) 10 mg Warfarin Alone (Reference)
Hide Arm/Group Description:
Period 2: Day -1=participant admission; Days 1 to 12=18-mg LY2216684 oral dose, once daily; Day 3=single 10-mg warfarin oral dose; Day 13=discharge.
Period 1: Day -1=participant admission; Day 1=single 10-mg warfarin oral dose; Day 11=discharge. Washout Period: at least 14 days between last dose in Period 1 and first dose in Period 2.
Overall Number of Participants Analyzed 16 15
Geometric Mean (90% Confidence Interval)
Unit of Measure: nanogram*hour per milliliter (ng*hr/mL)
22200
(19900 to 24700)
20800
(18700 to 23200)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg Warfarin + 18 mg LY2216684 (Test), 10 mg Warfarin Alone (Reference)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.07
Confidence Interval (2-Sided) 90%
1.00 to 1.13
Estimation Comments [Not Specified]
2.Primary Outcome
Title Pharmacokinetics: Maximum Plasma Concentration (Cmax) of S-Warfarin
Time Frame Pre-dose, 1, 2, 3, 4, 5, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-warfarin administration on Days 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who received at least 1 dose of warfarin and had evaluable concentration data.
Arm/Group Title 10 mg Warfarin + 18 mg LY2216684 (Test) 10 mg Warfarin Alone (Reference)
Hide Arm/Group Description:
Period 2: Day -1=participant admission; Days 1 to 12=18-mg LY2216684 oral dose, once daily; Day 3=single 10-mg warfarin oral dose; Day 13=discharge.
Period 1: Day -1=participant admission; Day 1=single 10-mg warfarin oral dose; Day 11=discharge. Washout Period: at least 14 days between last dose in Period 1 and first dose in Period 2.
Overall Number of Participants Analyzed 16 15
Geometric Mean (90% Confidence Interval)
Unit of Measure: nanogram per milliliter (ng/mL)
633.00
(576.78 to 694.70)
566.57
(516.06 to 622.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg Warfarin + 18 mg LY2216684 (Test), 10 mg Warfarin Alone (Reference)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.12
Confidence Interval (2-Sided) 90%
1.07 to 1.16
Estimation Comments [Not Specified]
3.Primary Outcome
Title Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of S-Warfarin
Hide Description This outcome was measured based on Tmax of S-warfarin on Day 1 of Period 1 when warfarin was administered alone (reference) and on Day 3 of Period 2 when coadministered with LY2216684 (test).
Time Frame Pre-dose, 1, 2, 3, 4, 5, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-warfarin administration on Days 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who had at least 1 dose of warfarin and had evaluable concentration data.
Arm/Group Title 10 mg Warfarin + 18 mg LY2216684 (Test) 10 mg Warfarin Alone (Reference)
Hide Arm/Group Description:
Period 2: Day -1=participant admission; Days 1 to 12=18-mg LY2216684 oral dose, once daily; Day 3=single 10-mg warfarin oral dose; Day 13=discharge.
Period 1: Day -1=participant admission; Day 1=single 10-mg warfarin dose; Day 11=discharge. Washout Period: at least 14 days between last dose in Period 1 and first dose in Period 2.
Overall Number of Participants Analyzed 15 15
Median (Full Range)
Unit of Measure: hour (h)
3.00
(1.00 to 5.00)
3.00
(1.00 to 4.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg Warfarin + 18 mg LY2216684 (Test), 10 mg Warfarin Alone (Reference)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9551
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.50 to 0.50
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of R-Warfarin
Hide Description Least Squares (LS) geometric mean was based on AUC0-∞ of R-warfarin; calculated when warfarin was administered alone (reference) on Day 1 of Period 1 and coadministered with LY2216684 (test) on Day 3 of Period 2.
Time Frame Pre-dose, 1, 2, 3, 4, 5, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-warfarin administration on Days 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who had at least 1 dose of warfarin and evaluable concentration data.
Arm/Group Title 10 mg Warfarin + 18 mg LY2216684 (Test) 10 mg Warfarin Alone (Reference)
Hide Arm/Group Description:
Period 2: Day -1=participant admission; Days 1 to 12=18-mg LY2216684 oral dose, once daily; Day 3=single 10-mg warfarin oral dose; Day 13=discharge.
Period 1: Day -1=participant admission; Day 1=single 10-mg warfarin oral dose; Day 11=discharge. Washout Period: at least 14 days between last dose in Period 1 and first dose in Period 2.
Overall Number of Participants Analyzed 16 15
Geometric Mean (90% Confidence Interval)
Unit of Measure: ng*h/mL
43600
(39600 to 48000)
38000
(34500 to 41800)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg Warfarin + 18 mg LY2216684 (Test), 10 mg Warfarin Alone (Reference)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.15
Confidence Interval (2-Sided) 90%
1.10 to 1.20
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Pharmacokinetics: Maximum Plasma Concentration (Cmax) of R-Warfarin
Time Frame Pre-dose, 1, 2, 3, 4, 5, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-warfarin administration on Days 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who had at least 1 dose of warfarin and evaluable concentration data.
Arm/Group Title 10 mg Warfarin + 18 mg LY2216684 (Test) 10 mg Warfarin Alone (Reference)
Hide Arm/Group Description:
Period 2: Day -1=participant admission; Days 1 to 12=18-mg LY2216684 oral dose, once daily; Day 3=single 10-mg warfarin oral dose; Day 13=discharge.
Period 1: Day -1=participant admission; Day 1=single 10-mg warfarin oral dose; Day 11=discharge. Washout Period: at least 14 days between last dose in Period 1 and first dose in Period 2.
Overall Number of Participants Analyzed 16 15
Geometric Mean (90% Confidence Interval)
Unit of Measure: ng/mL
669.25
(607.10 to 737.76)
592.38
(537.19 to 653.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg Warfarin + 18 mg LY2216684 (Test), 10 mg Warfarin Alone (Reference)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.13
Confidence Interval (2-Sided) 90%
1.09 to 1.17
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Pharmacokinetics: Time to Maximum Concentration (Tmax) of R-Warfarin
Hide Description This outcome was measured based on Tmax of R-warfarin on Day 1 of Period 1 when warfarin was administered alone (reference) and on Day 3 of Period 2 when coadministered with LY2216684 (test).
Time Frame Pre-dose, 1, 2, 3, 4, 5, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-warfarin administration on Days 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who had at least 1 dose of warfarin and evaluable concentration data.
Arm/Group Title 10 mg Warfarin + 18 mg LY2216684 (Test) 10 mg Warfarin Alone (Reference)
Hide Arm/Group Description:
Period 2: Day -1=participant admission; Days 1 to 12=18-mg LY2216684 oral dose, once daily; Day 3=single 10-mg warfarin oral dose; Day 13=discharge.
Period 1: Day -1=participant admission; Day 1=single 10-mg warfarin oral dose; Day 11=discharge. Washout Period: at least 14 days between last dose in Period 1 and first dose in Period 2.
Overall Number of Participants Analyzed 15 15
Median (Full Range)
Unit of Measure: h
3.02
(2.00 to 5.00)
4.00
(2.00 to 8.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg Warfarin + 18 mg LY2216684 (Test), 10 mg Warfarin Alone (Reference)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6094
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.50 to 0.02
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Pharmacodynamics: Area Under the Curve of the International Normalized Ratio (AUCINR) of Warfarin
Hide Description The INR is the ratio of a participant's prothrombin time to a normal (control) sample. AUCINR was calculated when warfarin was administered alone (reference) on Day 1 of Period 1 and coadministered with LY2216684 (test) on Day 3 of Period 2.
Time Frame Predose, 6, 12, 24, 48, 72, 96, 120, 144 hours post-warfarin administration on Days 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who had at least 1 dose of warfarin and evaluable concentration data.
Arm/Group Title 10 mg Warfarin + 18 mg LY2216684 (Test) 10 mg Warfarin Alone (Reference)
Hide Arm/Group Description:
Period 2: Day -1=participant admission; Days 1 to 12=18-mg LY2216684 oral dose, once daily; Day 3=single 10-mg warfarin oral dose; Day 13=discharge.
Period 1: Day -1=participant admission; Day 1=single 10-mg warfarin oral dose; Day 11=discharge. Washout Period: at least 14 days between last dose in Period 1 and first dose in Period 2.
Overall Number of Participants Analyzed 16 15
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: ratio
155
(152 to 157)
149
(147 to 152)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg Warfarin + 18 mg LY2216684 (Test), 10 mg Warfarin Alone (Reference)
Comments Least Squares (LS) geometric mean was based on pharmacodynamic AUCINR of warfarin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.04
Confidence Interval (2-Sided) 90%
1.02 to 1.05
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Pharmacodynamics: Maximum Observed International Normalized Ratio (INRmax)
Hide Description INR is the ratio of a participant's prothrombin time to a normal (control) sample. INRmax was calculated when warfarin was administered alone (reference) on Day 1 of Period 1 and coadministered with LY2216684 (test) on Day 3 of Period 2.
Time Frame Predose, 6, 12, 24, 48, 72, 96, 120, 144 hours post-warfarin administration on Days 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included participants who had at least 1 dose of warfarin and evaluable concentration data.
Arm/Group Title 10 mg Warfarin + 18 mg LY2216684 (Test) 10 mg Warfarin Alone (Reference)
Hide Arm/Group Description:
Period 2: Day -1=participant admission; Days 1 to 12=18-mg LY2216684 oral dose, once daily; Day 3=single 10-mg warfarin oral dose; Day 13=discharge.
Period 1: Day -1=participant admission; Day 1=single 10-mg warfarin oral dose; Day 11=discharge. Washout Period: at least 14 days between last dose in Period 1 and first dose in Period 2.
Overall Number of Participants Analyzed 16 15
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: ratio
1.19
(1.15 to 1.24)
1.14
(1.10 to 1.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10 mg Warfarin + 18 mg LY2216684 (Test), 10 mg Warfarin Alone (Reference)
Comments Least Squares (LS) geometric mean was based on pharmacodynamic INRmax of warfarin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.04
Confidence Interval (2-Sided) 90%
1.01 to 1.08
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 10 mg Warfarin + 18 mg LY2216684 (Test) 10 mg Warfarin Alone (Reference) 18 mg LY2216684 Alone
Hide Arm/Group Description Period 2: Day -1=participant admission; Days 1 to 12=18-mg LY2216684 oral dose, once daily; Day 3=single 10-mg warfarin oral dose; Day 13=discharge. Period 1: Day -1=participant admission; Day 1=single 10-mg warfarin oral dose; Day 11=discharge. Washout Period: at least 14 days between last dose in Period 1 and first dose in Period 2. Period 2: 18-mg LY2216684 oral dose, once daily on Days 1 to 12.
All-Cause Mortality
10 mg Warfarin + 18 mg LY2216684 (Test) 10 mg Warfarin Alone (Reference) 18 mg LY2216684 Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
10 mg Warfarin + 18 mg LY2216684 (Test) 10 mg Warfarin Alone (Reference) 18 mg LY2216684 Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/18 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
10 mg Warfarin + 18 mg LY2216684 (Test) 10 mg Warfarin Alone (Reference) 18 mg LY2216684 Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/16 (50.00%)      6/18 (33.33%)      8/16 (50.00%)    
Cardiac disorders       
Palpitations  1  3/16 (18.75%)  3 0/18 (0.00%)  0 0/16 (0.00%)  0
Eye disorders       
Vision blurred  1  0/16 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension  1  1/16 (6.25%)  2 0/18 (0.00%)  0 0/16 (0.00%)  0
Abdominal pain  1  1/16 (6.25%)  1 0/18 (0.00%)  0 1/16 (6.25%)  1
Constipation  1  0/16 (0.00%)  0 1/18 (5.56%)  1 2/16 (12.50%)  2
Gastrooesophageal reflux disease  1  0/16 (0.00%)  0 0/18 (0.00%)  0 1/16 (6.25%)  1
Lip dry  1  0/16 (0.00%)  0 2/18 (11.11%)  2 0/16 (0.00%)  0
Nausea  1  0/16 (0.00%)  0 0/18 (0.00%)  0 4/16 (25.00%)  4
Vomiting  1  0/16 (0.00%)  0 0/18 (0.00%)  0 3/16 (18.75%)  3
General disorders       
Asthenia  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Chest discomfort  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Chills  1  0/16 (0.00%)  0 0/18 (0.00%)  0 3/16 (18.75%)  3
Fatigue  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Feeling hot  1  0/16 (0.00%)  0 0/18 (0.00%)  0 1/16 (6.25%)  1
Feeling jittery  1  1/16 (6.25%)  1 0/18 (0.00%)  0 1/16 (6.25%)  1
Vessel puncture site pain  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Myalgia  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Pain in extremity  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Nervous system disorders       
Dizziness  1  1/16 (6.25%)  1 0/18 (0.00%)  0 2/16 (12.50%)  2
Headache  1  2/16 (12.50%)  2 0/18 (0.00%)  0 0/16 (0.00%)  0
Loss of consciousness  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Somnolence  1  1/16 (6.25%)  1 0/18 (0.00%)  0 4/16 (25.00%)  4
Psychiatric disorders       
Anxiety  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Depression  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Renal and urinary disorders       
Urinary hesitation  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Epistaxis  1  0/16 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dry skin  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Ecchymosis  1  1/16 (6.25%)  1 1/18 (5.56%)  1 0/16 (0.00%)  0
Rash  1  0/16 (0.00%)  0 1/18 (5.56%)  1 0/16 (0.00%)  0
Vascular disorders       
Flushing  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Peripheral coldness  1  1/16 (6.25%)  1 0/18 (0.00%)  0 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01263119     History of Changes
Other Study ID Numbers: 12595
H9P-EW-LNCF ( Other Identifier: Eli Lilly and Company )
First Submitted: December 16, 2010
First Posted: December 20, 2010
Results First Submitted: February 17, 2018
Results First Posted: October 19, 2018
Last Update Posted: January 21, 2019