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Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease (SWAP-2)

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ClinicalTrials.gov Identifier: NCT01587651
Recruitment Status : Completed
First Posted : April 30, 2012
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Interventions Drug: Prasugrel Loading Dose
Drug: Prasugrel Maintenance Dose
Drug: Ticagrelor Maintenance Dose
Enrollment 110
Recruitment Details All subjects must have been taking low dose aspirin (ASA) (75 mg to 150 mg once daily-QD) for at least 7 days prior to Screening (Visit 1), and must have continued the same regimen throughout the study.
Pre-assignment Details The study consisted of a 3 to 5 day ticagrelor run-in phase followed by randomized treatment on 1 of 2 prasugrel regimens or continued ticagrelor
Arm/Group Title Prasugrel Loading Dose Prasugrel Maintenance Dose Ticagrelor Maintenance Dose
Hide Arm/Group Description

Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)

Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet

Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets

Prasugrel 10 mg QD MD

Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet

Ticagrelor 90 mg twice-daily (BID) MD

Ticagrelor Maintenance Dose : one 90mg film coated tablet

Period Title: Overall Study
Started 34 41 35
Completed 34 38 34
Not Completed 0 3 1
Reason Not Completed
Adverse Event             0             1             0
Protocol Violation             0             1             1
Withdrawal by Subject             0             1             0
Arm/Group Title Prasugrel Loading Dose Prasugrel Maintenance Dose Ticagrelor Maintenance Dose Total
Hide Arm/Group Description

Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)

Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet

Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets

Prasugrel 10 mg QD MD

Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet

Ticagrelor 90 mg twice-daily (BID) MD

Ticagrelor Maintenance Dose : one 90mg film coated tablet

Total of all reporting groups
Overall Number of Baseline Participants 34 41 35 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 41 participants 35 participants 110 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
  70.6%
28
  68.3%
22
  62.9%
74
  67.3%
>=65 years
10
  29.4%
13
  31.7%
13
  37.1%
36
  32.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 41 participants 35 participants 110 participants
57.8  (9.69) 58.5  (8.84) 61.5  (6.87) 59.2  (8.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 41 participants 35 participants 110 participants
Female
10
  29.4%
11
  26.8%
8
  22.9%
29
  26.4%
Male
24
  70.6%
30
  73.2%
27
  77.1%
81
  73.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 41 participants 35 participants 110 participants
Hispanic or Latino
1
   2.9%
3
   7.3%
4
  11.4%
8
   7.3%
Not Hispanic or Latino
33
  97.1%
36
  87.8%
30
  85.7%
99
  90.0%
Unknown or Not Reported
0
   0.0%
2
   4.9%
1
   2.9%
3
   2.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 41 participants 35 participants 110 participants
American Indian or Alaska Native
1
   2.9%
0
   0.0%
0
   0.0%
1
   0.9%
Asian
0
   0.0%
1
   2.4%
0
   0.0%
1
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  20.6%
7
  17.1%
4
  11.4%
18
  16.4%
White
26
  76.5%
33
  80.5%
30
  85.7%
89
  80.9%
More than one race
0
   0.0%
0
   0.0%
1
   2.9%
1
   0.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 41 participants 35 participants 110 participants
United States 30 36 32 98
United Kingdom 4 5 3 12
weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 34 participants 41 participants 35 participants 110 participants
97.0  (17.70) 95.4  (18.85) 89.4  (19.35) 94.0  (18.77)
height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 34 participants 41 participants 35 participants 110 participants
171.2  (8.74) 171.9  (10.15) 174.3  (9.14) 172.4  (9.41)
body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 34 participants 41 participants 35 participants 110 participants
33.2  (5.88) 32.3  (5.92) 29.2  (4.82) 31.6  (5.77)
diabetes mellitus history   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 41 participants 35 participants 110 participants
14 12 5 31
[1]
Measure Description: number of participants with diabetes mellitus sum of categories does not equal number of participants due to not all participants having this specific medical condition
hypertension history   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 41 participants 35 participants 110 participants
26 29 24 79
[1]
Measure Description: number of participants with hypertension susum of categories does not equal number of participants due to not all participants having this specific medical condition
hyperlipidemia history   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 41 participants 35 participants 110 participants
32 35 31 98
[1]
Measure Description: number of participants with hyperlipidemia sum of categories does not equal number of participants due to not all participants having this specific medical condition
peripheral artery disease history   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 41 participants 35 participants 110 participants
2 1 2 5
[1]
Measure Description: number of participants with peripheral artery disease (PAD) sum of categories does not equal number of participants due to not all participants having this specific medical condition
body mass index category   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 41 participants 35 participants 110 participants
< 30 kg/m^2 13 16 24 53
>= 30 kg/m^2 21 24 11 56
Unknown 0 1 0 1
[1]
Measure Description: body mass index <30 kg/m^2 or >= 30 kg/m^2 sum of categories does not equal number of participants due to missing data for 1 subject
1.Primary Outcome
Title P2Y12 Reaction Units
Hide Description P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. Platelet aggregation with this system is defined by PRU, with a higher PRU indicative of greater platelet aggregation, and a lower PRU indicative of inhibition.
Time Frame 7 days after first randomized dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary Population includes all subjects who received at least 1 dose of randomized study drug and have valid PRU data at both randomization visit pre-dosing and end-of-treatment visit. A subject is considered to have valid PRU data for primary PD analyses if he/she does not have certain protocol deviations listed in Statistical Analysis Plan.
Arm/Group Title Prasugrel Combined Groups Ticagrelor
Hide Arm/Group Description:
combined Prasugrel loading dose and Prasugrel maintenance dose
[Not Specified]
Overall Number of Participants Analyzed 65 33
Least Squares Mean (Standard Error)
Unit of Measure: PRU (P2Y12 Reaction Units)
95.0  (6.18) 49.0  (8.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel Combined Groups, Ticagrelor
Comments ANCOVA model included treatment as a main effect and pre-randomization baseline PRU as a covariate. The combined prasugrel groups were modeled as a single treatment. If the upper limit of the CI for the mean difference was not greater than 45 PRU, then the PD response to prasugrel 10 mg QD MD was deemed noninferior to that achieved by ticagrelor 90 mg BID MD.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority was assessed using a 95% CI of the difference in mean PRU between ticagrelor and prasugrel (2 arms combined). Under the assumption of 0 difference in mean PRU between prasugrel 10 mg QD MD and ticagrelor 90 mg BID MD, a common SD of 60 PRU (based on previous DSI studies and published data), and a drop-out rate not exceeding 15%, a sample size of 105 allows for the 95% CI to stay within ± 45 PRU (non-inferiority margin) with a power of 90%.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 46.0
Confidence Interval (2-Sided) 95%
24.9 to 67.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 10.66
Estimation Comments [Not Specified]
2.Secondary Outcome
Title P2Y12 Reaction Units
Hide Description P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay measured at 2, 4, 24, 48 hours after first randomized study treatment
Time Frame 2, 4, 24, 48 hours after first randomized dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary Population
Arm/Group Title Prasugrel Combined Groups Ticagrelor Prasugrel Loading Dose Prasugrel Maintenance Dose
Hide Arm/Group Description:
combined Prasugrel loading dose and Prasugrel maintenance dose
[Not Specified]
prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
prasugrel 10 mg QD for 7 days
Overall Number of Participants Analyzed 65 33 31 34
Least Squares Mean (Standard Error)
Unit of Measure: PRU
2 hours 33.7  (3.18) 28.9  (4.24) 22.1  (4.22) 44.8  (4.15)
4 hours 41.1  (3.67) 29.3  (4.54) 24.1  (4.69) 57.0  (4.53)
24 hours 126.8  (7.57) 47.6  (8.71) 81.6  (8.86) 167.8  (8.44)
48 hours 159.3  (7.68) 38.6  (9.07) 118.3  (9.22) 199.0  (9.07)
3.Secondary Outcome
Title Platelet Reactivity Index
Hide Description

Platelet Reactivity Index (PRI) by the Vasodilator-Stimulated Phosphoprotein(VASP) assay 2, 4, 24, 48 hours and 7 days after first randomized study treatment.

The VASP assay is an indirect, but relatively specific measure of inhibition of P2Y12-induced platelet activation. The assay quantifies the level of phosphorylation of the intracellular protein VASP, which undergoes phosphorylation when platelet P2Y12 receptors are blocked. The level of VASP phosphorylation, expressed as the PRI, represents the percentage inhibition relative to an assay baseline/maximal P2Y12-independent platelet aggregation.

Time Frame 2, 4, 24, 48 hours, 7 days after first randomized dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary Population
Arm/Group Title Prasugrel Combined Groups Ticagrelor Prasugrel Loading Dose Prasugrel Maintenance Dose
Hide Arm/Group Description:
combined Prasugrel loading dose and Prasugrel maintenance dose
[Not Specified]
prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
prasugrel 10 mg QD for 7 days
Overall Number of Participants Analyzed 65 33 31 34
Least Squares Mean (Standard Error)
Unit of Measure: percentage PRI
2 hours post-dose 18.2  (1.37) 13.2  (1.85) 15.8  (1.94) 20.4  (1.87)
4 hours post-dose 16.3  (1.58) 14.3  (2.06) 11.4  (2.16) 20.9  (2.08)
24 hours post-dose 34.3  (2.24) 19.1  (2.71) 24.2  (2.85) 43.7  (2.74)
48 hours post-dose 48.1  (2.58) 18.7  (3.20) 38.0  (3.37) 57.7  (3.30)
7 days post-dose 33.5  (2.64) 19.8  (3.58) 38.8  (3.87) 29.1  (3.50)
4.Secondary Outcome
Title PRU Percent Inhibition (Device-reported)
Hide Description

PRU VerifyNow P2Y12 assay device-reported percent inhibition 2, 4, 24, and 48 hours, and 7 days after first randomized study treatment

VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. The percent inhibition reported by VerifyNow device represents the percentage inhibition relative to maximal P2Y12-independent platelet aggregation achieved with the same sample in the presence of the iso-thrombin receptor activating peptide.

Time Frame 2, 4, 24, 48 hours, 7 days after first randomized dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary population
Arm/Group Title Prasugrel Combined Groups Ticagrelor Prasugrel Loading Dose Prasugrel Maintenance Dose
Hide Arm/Group Description:
combined Prasugrel loading dose and Prasugrel maintenance dose
[Not Specified]
prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
prasugrel 10 mg QD for 7 days
Overall Number of Participants Analyzed 65 33 31 34
Least Squares Mean (Standard Error)
Unit of Measure: percent inhibition
2 hours post-dose 87.8  (1.13) 89.2  (1.53) 91.4  (1.53) 84.3  (1.51)
4 hours post-dose 84.9  (1.25) 89.6  (1.58) 90.2  (1.63) 79.8  (1.58)
24 hours post-dose 54.1  (2.68) 81.9  (3.13) 69.6  (3.18) 40.0  (3.03)
48 hours post-dose 42.3  (2.79) 85.8  (3.19) 58.3  (3.24) 26.8  (3.19)
7 days post-dose 65.5  (2.17) 81.0  (3.07) 65.6  (3.16) 65.4  (3.02)
5.Secondary Outcome
Title PRU Percent Inhibition (Calculated)
Hide Description

Analysis of Mean Calculated Percent Inhibition by time point

Calculated percent inhibition at time point t is defined as: 100 × (baseline PRU – PRUt)/baseline PRU where baseline PRU is the VerifyNow PRU value at pre-run-in baseline and PRUt is the VerifyNow PRU value at time t.

Time Frame 2, 4, 24, 48 hours, 7 days after first randomized dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary population
Arm/Group Title Prasugrel Combined Groups Ticagrelor Prasugrel Loading Dose Prasugrel Maintenance Dose
Hide Arm/Group Description:
combined Prasugrel loading dose and Prasugrel maintenance dose
[Not Specified]
prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
prasugrel 10 mg QD for 7 days
Overall Number of Participants Analyzed 65 33 31 34
Least Squares Mean (Standard Error)
Unit of Measure: Percent Inhibition
2 hours post-dose 88.22  (1.113) 89.73  (1.476) 92.55  (1.475) 84.15  (1.429)
4 hours post dose 85.06  (1.319) 89.26  (1.632) 91.36  (1.686) 79.35  (1.605)
24 hours post dose 53.63  (2.851) 81.86  (3.237) 71.40  (3.291) 38.01  (3.085)
48 hours post dose 41.59  (2.911) 85.06  (3.388) 57.98  (3.438) 26.20  (3.332)
7 days psot dose 64.97  (2.336) 80.69  (3.322) 64.97  (3.429) 64.97  (3.221)
6.Secondary Outcome
Title Percentage of Subjects With High On-treatment Platelet Reactivity
Hide Description

Percentage of subjects with High on-treatment Platelet Reactivity (HPR) defined as a) >= 208 PRU and b) >= 230 PRU by the VerifyNow P2Y12 assay and c) >50% PRI by the VASP assay, 2, 4, 24, and 48 hours and 7 days after first randomized study treatment.

A poor response of the platelets to "drug", called High Residual Platelet Reactivity (HRPR), has been incriminated to account for a recurrence of ischemic events

Time Frame 2, 4, 24, 48 hours, 7 days after first randomized dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary population
Arm/Group Title Prasugrel Combined Groups Ticagrelor Prasugrel Loading Dose Prasugrel Maintenance Dose
Hide Arm/Group Description:
combined Prasugrel loading dose and Prasugrel maintenance dose
[Not Specified]
prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
prasugrel 10 mg QD for 7 days
Overall Number of Participants Analyzed 65 33 31 34
Measure Type: Number
Unit of Measure: percentage of subjects
>= 208 PRU 2 hours post dose 0 0 0 0
>= 208 PRU 4 hours post dose 0 0 0 0
>= 208 PRU 24 hours post dose 17.5 0 3.3 37.5
>= 208 PRU 48 hours post dose 30.2 0 16.1 43.8
>= 208 PRU 7 days post dose 1.5 3 3.2 0
>= 230 PRU by VerifyNow P2Y12 2 hours post dose 0 0 0 0
>= 230 PRU by VerifyNow P2Y12 4 hours post dose 0 0 0 0
>= 230 PRU by VerifyNow P2Y12 24 hours post dose 14.3 0 3.3 24.2
>= 230 PRU by VerifyNow P2Y12 48 hours post dose 22.2 0 6.5 37.5
>= 230 PRU by VerifyNow P2Y12 7 days post dose 1.5 3 3.2 0
>50% PRI by VASP assay 2 hours post dose 3.5 3.3 3.6 3.4
>50% PRI by VASP assay 4 hours post dose 1.8 3.3 0 3.4
>50% PRI by VASP assay 24 hours post dose 21.3 12.9 3.4 37.5
>50% PRI by VASP assay 48 hours post dose 45 6.3 13.8 74.2
>50% PRI by VASP assay 7 days post dose 15.5 3.4 23.1 9.4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prasugrel Loading Dose Prasugrel Maintenance Dose Ticagrelor Maintenance Dose
Hide Arm/Group Description

Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)

Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet

Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets

Prasugrel 10 mg QD MD

Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet

Ticagrelor 90 mg twice-daily (BID) MD

Ticagrelor Maintenance Dose : one 90mg film coated tablet

All-Cause Mortality
Prasugrel Loading Dose Prasugrel Maintenance Dose Ticagrelor Maintenance Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prasugrel Loading Dose Prasugrel Maintenance Dose Ticagrelor Maintenance Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      0/41 (0.00%)      1/35 (2.86%)    
Cardiac disorders       
congestive heart failure  0/34 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1
Injury, poisoning and procedural complications       
alcohol poisoning  0/34 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders       
depression  0/34 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders       
pneumonia  0/34 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Prasugrel Loading Dose Prasugrel Maintenance Dose Ticagrelor Maintenance Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/34 (23.53%)      10/41 (24.39%)      12/35 (34.29%)    
Cardiac disorders       
angina pectoris  1/34 (2.94%)  1 0/41 (0.00%)  0 0/35 (0.00%)  0
Eye disorders       
vision blurred  1/34 (2.94%)  1 0/41 (0.00%)  0 0/35 (0.00%)  0
Gastrointestinal disorders       
diarrhoea  1/34 (2.94%)  1 0/41 (0.00%)  0 0/35 (0.00%)  0
periodontal disease  0/34 (0.00%)  0 1/41 (2.44%)  1 0/35 (0.00%)  0
General disorders       
injection site haematoma  0/34 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1
Immune system disorders       
allergic oedema  0/34 (0.00%)  0 1/41 (2.44%)  1 0/35 (0.00%)  0
Infections and infestations       
upper respiratory tract infection  1/34 (2.94%)  1 0/41 (0.00%)  0 2/35 (5.71%)  2
nasopharyngitis  0/34 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1
Injury, poisoning and procedural complications       
laceration  0/34 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1
muscle strain  0/34 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1
Investigations       
alanine aminotransferase increased  1/34 (2.94%)  1 0/41 (0.00%)  0 0/35 (0.00%)  0
Metabolism and nutrition disorders       
hypomagnesaemia  0/34 (0.00%)  0 1/41 (2.44%)  1 0/35 (0.00%)  0
Musculoskeletal and connective tissue disorders       
arthralgia  0/34 (0.00%)  0 1/41 (2.44%)  1 0/35 (0.00%)  0
costochondritis  0/34 (0.00%)  0 1/41 (2.44%)  1 0/35 (0.00%)  0
pain in extremity  0/34 (0.00%)  0 1/41 (2.44%)  1 0/35 (0.00%)  0
Nervous system disorders       
headache  1/34 (2.94%)  1 1/41 (2.44%)  1 1/35 (2.86%)  1
Renal and urinary disorders       
renal failure  0/34 (0.00%)  0 1/41 (2.44%)  1 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
dyspnoea  0/34 (0.00%)  0 0/41 (0.00%)  0 2/35 (5.71%)  2
epistaxis  0/34 (0.00%)  0 0/41 (0.00%)  0 1/35 (2.86%)  1
Skin and subcutaneous tissue disorders       
eccymosis  3/34 (8.82%)  3 5/41 (12.20%)  5 4/35 (11.43%)  4
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.
Consultants may not publish in any way without the prior written consent of Daiichi Sankyo Inc., which consent may be witheld by DSI in its sole discretion, any material or manuscript relating to Consultant's work hereunder and/or any information or materials that Consultant received in connection with or pursuant to this Agreement or Consultant's relationship established with DSI.
Results Point of Contact
Name/Title: Fred Lipkin
Organization: Daiichi Sankyo Medical Affairs
Phone: 973-944-2216
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01587651     History of Changes
Other Study ID Numbers: CS747s-B-U4003
First Submitted: April 26, 2012
First Posted: April 30, 2012
Results First Submitted: February 11, 2014
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014