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CompletedNCT01107925FEATHERUpdated Aug 30, 2012Results posted

Comparison of Prasugrel and Clopidogrel in Low Body Weight Versus Higher Body Weight With Coronary Artery Disease

A Phase 1 interventional study of prasugrel and clopidogrel in Coronary Artery Disease, sponsored by Eli Lilly and Company. Completed at 6 sites in 4 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2012-08-30.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
01

Study summary

The 5-milligram (mg) dose of prasugrel in low body weight (LBW) patients with coronary artery disease produces a pharmacodynamic response within the same therapeutic range as 10-mg dose in higher body weight (HBW) patients.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Platelet function
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 72 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects with a history of stable coronary artery disease who are not currently indicated for treatment with a thienopyridine (that is, prasugrel, clopidogrel, or ticlopidine)
  • Provision of written informed consent
  • For women of child-bearing potential only (that is, women who are not surgically or chemically sterilised and who are between menarche and 1 year post menopause), test negative for pregnancy (based on a urine or serum pregnancy test to be performed before randomisation) and agree to use a reliable method of birth control during the study

Exclusion criteria

Exclusion Criteria:

  • Unstable coronary artery disease
  • Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft Surgery (CABG) within the previous 90 days
  • History of refractory ventricular arrhythmias within the last 6 months; an implanted defibrillator device; congestive heart failure within 6 months prior to screening; major surgery, or severe trauma, fracture or organ biopsy within 3 months prior to enrollment
  • Any planned surgical procedure or any coronary revascularisation (surgical or percutaneous) planned within 60 days following randomisation
  • Any known contraindication to treatment with an antiplatelet agent
  • Significant hypertension at the time of screening or randomisation
  • Clinically significant out-of-range values for platelet count or haemoglobin at screening, in the investigator's opinion, or results of clinical laboratory tests at the time of screening that are judged to be clinically significant for the study population, as determined by the investigator
  • Prior history or presence of significant bleeding disorders, abnormal bleeding tendency, or personal history of coagulation or bleeding disorders.
  • Prior history or clinical suspicion of cerebral vascular malformations, intracranial neoplasm, Transient Ischemic Attack (TIA) or stroke.
  • Prior history of thrombocytopenia or thrombocytosis
  • Use of antiplatelet agents (besides aspirin) within 10 days prior to screening; the use (or planned use) of heparin, oral anticoagulants, or fibrinolytic agents within 30 days of screening; or subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDS) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    5 mg prasugrel

    Drug: prasugrel

  • Active comparator
    10 mg prasugrel

    Drug: prasugrel

  • Active comparator
    75 mg clopidogrel

    Drug: clopidogrel

Interventions

  • Drugprasugrel

    Administered orally, daily for 12 days

    Also known as: Efient, Effient, LY640315, CS747

  • Drugclopidogrel

    Administered orally, daily for 12 days

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1)

    MPA to 20 micromolar (μM) ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.

    Time frame: Baseline, Day 12

Secondary outcomes

  1. Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy

    VASP phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition and were used to compare prasugrel versus clopidogrel, in low body weight (LBW) participants compared to higher body weight (HBW) participants. PRI was calculated by VASP. The PRI indicates the level of P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12 receptor thus stronger platelet inhibition, whereas a higher PRI reflects weaker inhibition of P2Y12 receptor and weaker platelet inhibition.

    Time frame: Baseline, Day 12

  2. Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy

    The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in PRU. PRU indicates the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of rate and extent of platelet aggregation in an adenosine phosphate (ADP)-containing channel of the device. A lower PRU reflects stronger inhibition of platelet aggregation, whereas a higher PRU reflects weaker inhibition of platelet aggregation.

    Time frame: Baseline, Day 12

  3. Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC)

    A pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing MPA (LTA) and AUC was conducted as originally intended, however the graphic output is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours \[AUC (0-4)\] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.

    Time frame: baseline (pre-dose) up to 4 hours post-dose

  4. Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy

    MPA to 20 micromolar (μM) adenosine diphosphate (ADP) was assessed by LTA, an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.

    Time frame: Baseline , Day 12

07

Results

Posted Aug 30, 2012

Participant flow

Period 1-Randomization up Through Day 12
Participant flow — Period 1-Randomization up Through Day 12
Milestone5 mg Prasugrel (LBW)10 mg Prasugrel (LBW)75 mg Clopidogrel (LBW)5 mg Prasugrel (HBW)10 mg Prasugrel (HBW)75 mg Clopidogrel (HBW)
Started34000380
Took at least 1 dose of study drug34000380
Completed33000370
Not completed100010
Withdrew: Withdrawal by subject100010
Period 2
Participant flow — Period 2
Milestone5 mg Prasugrel (LBW)10 mg Prasugrel (LBW)75 mg Clopidogrel (LBW)5 mg Prasugrel (HBW)10 mg Prasugrel (HBW)75 mg Clopidogrel (HBW)
Started0161720017
Took at least 1 dose of study drug0161720017
Completed0151720016
Not completed010001
Withdrew: Withdrawal by subject010001
Period 3
Participant flow — Period 3
Milestone5 mg Prasugrel (LBW)10 mg Prasugrel (LBW)75 mg Clopidogrel (LBW)5 mg Prasugrel (HBW)10 mg Prasugrel (HBW)75 mg Clopidogrel (HBW)
Started0171516020
Took at least 1 dose of study drug0171516020
Completed0171516020
Not completed000000

Outcome measures

PrimaryChange From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1)

MPA to 20 micromolar (μM) ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.

Time frame:
Baseline, Day 12
Reported as:
Median · percent aggregation
Change From Baseline in Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12 (Period 1)
percent aggregationPrasugrel 5 mg (LBW)Prasugrel 10 mg (HBW)
Baseline75.00 (70.00 to 80.00)76.40 (71.00 to 84.10)
Day 12 (n=32, 37)47.00 (37.70 to 56.45)47.00 (39.00 to 57.10)
Statistical analysis
  • Prasugrel 5 mg (LBW) vs Prasugrel 10 mg (HBW) · bootstrap (to determine 95% CI) · p = 0.526 · Estimate of the difference: -10.10 · 95% CI -23.40 to 0.20Estimate of the difference = \[median (low body weight) - Q3 (higher body weight)\]
SecondaryChange From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy

VASP phosphorylation levels, expressed as the platelet reactivity index (PRI), reflect the degree of thienopyridine-mediated P2Y12 receptor inhibition and were used to compare prasugrel versus clopidogrel, in low body weight (LBW) participants compared to higher body weight (HBW) participants. PRI was calculated by VASP. The PRI indicates the level of P2Y12 receptor inhibition. A lower PRI reflects stronger inhibition of P2Y12 receptor thus stronger platelet inhibition, whereas a higher PRI reflects weaker inhibition of P2Y12 receptor and weaker platelet inhibition.

Time frame:
Baseline, Day 12
Reported as:
Mean · percentage PRI
Change From Baseline in Vasodilator-Associated Stimulated Phosphoprotein (VASP) at Day 12 of Therapy
percentage PRI5 mg Prasugrel (LBW)10 mg Prasugrel (LBW)75 mg Clopidogrel (LBW)5 mg Prasugrel (HBW)10 mg Prasugrel (HBW)75 mg Clopidogrel (HBW)
Baseline86.57 ± 4.4486.44 ± 4.4586.44 ± 4.4586.77 ± 3.4286.76 ± 3.3786.77 ± 3.42
Day 12 (n=32,31,30,32,36,34)33.54 ± 15.7715.09 ± 11.7139.01 ± 17.4956.87 ± 15.4727.79 ± 18.1356.35 ± 18.33
SecondaryChange From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy

The Accumetrics VerifyNow® P2Y12 assay measures platelet aggregation in whole blood and is reported in PRU. PRU indicates the extent of P2Y12 receptor-mediated platelet aggregation calculated as a function of rate and extent of platelet aggregation in an adenosine phosphate (ADP)-containing channel of the device. A lower PRU reflects stronger inhibition of platelet aggregation, whereas a higher PRU reflects weaker inhibition of platelet aggregation.

Time frame:
Baseline, Day 12
Reported as:
Mean · P2Y12 reaction units (PRU)
Change From Baseline in VerifyNow® P2Y12 Reaction Units (PRU) at Day 12 of Therapy
P2Y12 reaction units (PRU)5 mg Prasugrel (LBW)10 mg Prasugrel (LBW)75 mg Clopidogrel (LBW)5 mg Prasugrel (HBW)10 mg Prasugrel (HBW)75 mg Clopidogrel (HBW)
Baseline317.9 ± 46.10315.3 ± 44.26315.3 ± 44.26312.8 ± 43.01311.0 ± 43.76312.8 ± 43.01
Day 12 (n=32,31,32,35,34,34)129.5 ± 62.1455.9 ± 38.08151.7 ± 57.46193.9 ± 74.09102.1 ± 69.49207.0 ± 67.62
SecondaryPharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC)

A pharmacokinetic-pharmacodynamic (PK-PD) analysis comparing MPA (LTA) and AUC was conducted as originally intended, however the graphic output is not possible here. Therefore, the PK portion is presented here as AUC and the PD portion is presented in Secondary Outcome Measure #5. AUC was calculated through the last scheduled sampling time of 4 hours \[AUC (0-4)\] or through the sampling time of the last quantifiable concentration prior to 4 hours. AUC values were denoted AUC(0-tlast) in both instances.

Time frame:
baseline (pre-dose) up to 4 hours post-dose
Reported as:
Geometric mean · nanogram•hour/milliliter (ng•hr/mL)
Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC)
nanogram•hour/milliliter (ng•hr/mL)Prasugrel 5 mg (LBW)Prasugrel 10 mg (LBW)Clopidogrel 75 mg (LBW)Prasugrel 5 mg (HBW)Prasugrel 10 mg (HBW)Clopidogrel 75 mg (HBW)
Pharmacokinetic (PK) Analysis of the Concentration-Time Curve (AUC)28.9 ± 3759.3 ± 4018.4 ± 3819.4 ± 4646.7 ± 4412.7 ± 60
SecondaryChange From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy

MPA to 20 micromolar (μM) adenosine diphosphate (ADP) was assessed by LTA, an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). A lower MPA reflects stronger platelet inhibition, whereas a higher MPA reflects weaker inhibition.

Time frame:
Baseline , Day 12
Reported as:
Mean · percent aggregation
Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) at Day 12 of Therapy
percent aggregation5 mg Prasugrel (LBW)10 mg Prasugrel (LBW)75 mg Clopidogrel (LBW)5 mg Prasugrel (HBW)10 mg Prasugrel (HBW)75 mg Clopidogrel (HBW)
Baseline76.27 ± 9.4976.20 ± 9.6376.20 ± 9.6377.63 ± 12.2977.93 ± 12.2777.63 ± 12.29
Day 12 ( n= 32,32,31,35,37,35)48.10 ± 13.8938.11 ± 14.1751.41 ± 13.5661.90 ± 18.9347.92 ± 15.1865.28 ± 17.83

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
5 mg Prasugrel (LBW)—0/34 (0%)20/34 (58.8%)
10 mg Prasugrel (LBW)—1/33 (3%)21/33 (63.6%)
75 mg Clopidogrel (LBW)—0/32 (0%)14/32 (43.8%)
5 mg Prasugrel (HBW)—0/36 (0%)10/36 (27.8%)
10 mg Prasugrel (HBW)—0/38 (0%)12/38 (31.6%)
75 mg Clopidogrel (HBW)—0/37 (0%)14/37 (37.8%)
Most frequent serious events
Most frequent serious events
Event5 mg Prasugrel (LBW)10 mg Prasugrel (LBW)75 mg Clopidogrel (LBW)5 mg Prasugrel (HBW)10 mg Prasugrel (HBW)75 mg Clopidogrel (HBW)
Subarachnoid haemorrhageNervous system disorders0/341/330/320/360/380/37
Most frequent other events
Showing 10 of 59
Most frequent other events
Event5 mg Prasugrel (LBW)10 mg Prasugrel (LBW)75 mg Clopidogrel (LBW)5 mg Prasugrel (HBW)10 mg Prasugrel (HBW)75 mg Clopidogrel (HBW)
ContusionInjury, poisoning and procedural complications6/349/331/320/363/382/37
HaematomaVascular disorders3/345/333/325/363/381/37
NasopharyngitisInfections and infestations3/340/330/320/360/380/37
Traumatic haematomaInjury, poisoning and procedural complications1/341/332/320/360/380/37
EpistaxisRespiratory, thoracic and mediastinal disorders1/342/331/321/361/382/37
NauseaGastrointestinal disorders2/340/331/320/362/382/37
PyrexiaGeneral disorders2/340/330/320/360/380/37
CoughRespiratory, thoracic and mediastinal disorders2/340/330/320/360/380/37
HeadacheNervous system disorders0/340/331/321/362/381/37
Abdominal pain upperGastrointestinal disorders0/340/331/320/361/380/37

Baseline characteristics

Age Continuous
Age Continuous(years)Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW)Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW)Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW)Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW)Total
Mean61.3 ± 8.0763.2 ± 7.6561.4 ± 9.5764.6 ± 6.9162.6 ± 8.15
Sex: Female, Male
Sex: Female, Male(Participants)Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW)Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW)Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW)Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW)Total
Female15147541
Male23141231
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW)Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW)Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW)Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW)Total
Hispanic or Latino00000
Not Hispanic or Latino10811837
Unknown or Not Reported7910935
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW)Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW)Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW)Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW)Total
American Indian or Alaska Native00000
Asian01001
Native Hawaiian or Other Pacific Islander00000
Black or African American00134
White1716201467
More than one race00000
Unknown or Not Reported00000
Region of Enrollment
Region of Enrollment(participants)Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW)Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW)Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW)Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW)Total
United States00224
Ireland228618
Netherlands985527
Sweden676423
Weight
Weight(kilograms (kg))Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW)Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW)Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW)Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW)Total
Mean56.06 ± 4.57556.78 ± 2.61983.60 ± 17.14685.96 ± 11.89871.33 ± 17.980
Tobacco Use Status
Tobacco Use Status(participants)Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW)Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW)Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW)Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW)Total
Tobacco Use Yes785424
Tobacco Use No109161348
08

Study locations

6 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Jacksonville, Florida 32209, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Cincinnati, Ohio 45212, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Dublin, 9, Ireland
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Nieuwegein, 3435 CM, Netherlands
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Lund, 22185, Sweden
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Uppsala, 75185, Sweden
09

References and documents

Publications

  • Jakubowski JA, Angiolillo DJ, Zhou C, Small DS, Moser BA, Ten Berg JM, Brown PB, James S, Winters KJ, Erlinge D. The influence of body size on the pharmacodynamic and pharmacokinetic response to clopidogrel and prasugrel: a retrospective analysis of the FEATHER study. Thromb Res. 2014 Sep;134(3):552-7. doi: 10.1016/j.thromres.2014.05.019. Epub 2014 May 21. PubMed 25022828 ↗
  • Erlinge D, Ten Berg J, Foley D, Angiolillo DJ, Wagner H, Brown PB, Zhou C, Luo J, Jakubowski JA, Moser B, Small DS, Bergmeijer T, James S, Winters KJ. Reduction in platelet reactivity with prasugrel 5 mg in low-body-weight patients is noninferior to prasugrel 10 mg in higher-body-weight patients: results from the FEATHER trial. J Am Coll Cardiol. 2012 Nov 13;60(20):2032-40. doi: 10.1016/j.jacc.2012.08.964. Epub 2012 Oct 17. PubMed 23083774 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01107925
Lead sponsor
Eli Lilly and Company
Collaborators
Daiichi Sankyo Co., Ltd.
Responsible party
Sponsor
First posted
Apr 21, 2010
Start date
Mar 2010
Primary completion
Aug 2011
Completion
Aug 2011
Results posted
Aug 30, 2012
Last update
Aug 30, 2012

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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