Back to resultsMultiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease
Primary Purpose
Atherosclerosis, Cardiovascular Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MEDI6012 40 mg
Placebo
MEDI6012 120 mg
MEDI6012 300 mg
Placebo IV Push
MEDI6012 IV Push
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring Atherosclerosis, Cardiovascular Disease, CAD, Atherosclerotic Cardiovascular Disease
Eligibility Criteria
Inclusion Criteria:
- Non-childbearing potential
- Diagnosis of stable atherosclerotic CVD
- Currently receiving a stable dose of Statin
Exclusion Criteria:
- Unstable cardiovascular condition within 3 months of screening
- Elective arterial revascularization with in the past month
- Any planned arterial revascularization
- Body mass index <18 or >45
- Clinically significant ECG that may interfere with the interpretation of serial ECG and QT interval changes at screening
- Chronic kidney disease defined by estimated glomerular filtration rate of less than 30 mL/mim/1.73m2
- Triglycerides greater than 500 mg/dL, LDL-C greater than 160 mg/dL, or HDL-C greater than 60 for males, or 65 for females
- Clinically significant vital sign abnormalities
- Genetic disorder of cholesterol metabolism
- History of overt liver disease
- Poorly controlled endocrine disorder (Diabetes or Thyroid disorder)
- Current or recent use of systemic corticosteroids
- Recent or ongoing infection or febrile illness
- History of active malignancy within 5 years
- History of alcohol or recreational substance abuse in the past 6 months
- Concurrent enrollment in another clinical study of any investigational drug therapy or use of any biologicals within 6 months prior to screening or within 5 half-lives of an investigational agent or biologic, whichever is longer.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
MEDI6012 40 mg
Placebo
MEDI6012 120 mg
MEDI6012 300 mg
MEDI6012 IV Push
Placebo IV Push
Arm Description
Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.
Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 56 days after last dose of study drug (Day 66 for Cohort 4 and placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm) that were absent before treatment or that worsened relative to pre-treatment state.
Number of Participants With Abnormal Clinical Laboratory Evaluations Reported as TEAEs
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, respiration rate, heart rate, pulse oximetry, and body temperature.
Number of Participants With Abnormal Electrocardiogram Reported as TEAEs
Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol (HDL-C)
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol Ester (HDL-CE)
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol ester.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Cholesterol Ester
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of cholesterol ester.
Secondary Outcome Measures
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein A1
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein A1.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Low-density Lipoprotein Cholesterol (LDL-C).
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of LDL-C.
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein B
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein B.
Change From Baseline in Serum Concentration for MEDI6012 Mass
The trough concentration level of MEDI6012 following each dose is reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).
Change From Baseline in Serum Concentration for Total LCAT Activity
Lecithin-cholesterol acyltransferase (LCAT) is a plasma enzyme secreted by the liver. Serum LCAT activity was estimated to provide an alternative measure to LCAT mass in establishing the relationship between pharmacokinetics and pharmacodynamics of MEDI6012. Change in LCAT activity from baseline (pre-dose of each dose) to post doses was reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).
Maximum Observed Serum Concentration (Cmax) of MEDI6012
The maximum observed serum concentration following the first and third dose of MEDI6012 was reported.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of MEDI6012
The time to reach the maximum observed serum concentration following the first and third dose of MEDI6012 was reported.
Accumulation Ratio (Rac) of MEDI6012
The accumulation ratio (Rac) is defined as the ratio of accumulation of a study drug going from a single dose to steady state with repeated administration. Accumulation ratio was reported on the basis of maximum concentration (ARC max) and area under the concentration-time curve (ARAUC).
Terminal Half-life (t1/2) of MEDI6012
The t1/2 is the time measured for the serum concentration to decrease by one half after the third dose of MEDI6012.
Area Under the Concentration Time Curve to Last Measurable Time Point (AUClast) of MEDI6012
The area under the concentration time-curve to the last measured concentration after the third dose of MEDI6012 was reported.
Number of Participants With Positive Anti-Drug Antibodies for MEDI6012
Participants with positive serum antibodies to MEDI6012 were reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03004638
Brief Title
Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease
Official Title
A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 23, 2017 (Actual)
Primary Completion Date
November 2, 2017 (Actual)
Study Completion Date
November 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of MEDI6012 in subjects with stable atherosclerosis.
Detailed Description
A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of MEDI6012 in Subjects with Stable Atherosclerotic Cardiovascular Disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Cardiovascular Disease
Keywords
Atherosclerosis, Cardiovascular Disease, CAD, Atherosclerotic Cardiovascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI6012 40 mg
Arm Type
Experimental
Arm Description
Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.
Arm Title
MEDI6012 120 mg
Arm Type
Experimental
Arm Description
Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
Arm Title
MEDI6012 300 mg
Arm Type
Experimental
Arm Description
Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
Arm Title
MEDI6012 IV Push
Arm Type
Experimental
Arm Description
Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
Arm Title
Placebo IV Push
Arm Type
Placebo Comparator
Arm Description
Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
Intervention Type
Drug
Intervention Name(s)
MEDI6012 40 mg
Intervention Description
Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.
Intervention Type
Drug
Intervention Name(s)
MEDI6012 120 mg
Intervention Description
Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
Intervention Type
Drug
Intervention Name(s)
MEDI6012 300 mg
Intervention Description
Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
Intervention Type
Drug
Intervention Name(s)
Placebo IV Push
Intervention Description
Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
Intervention Type
Drug
Intervention Name(s)
MEDI6012 IV Push
Intervention Description
Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Description
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 56 days after last dose of study drug (Day 66 for Cohort 4 and placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm) that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame
From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)
Title
Number of Participants With Abnormal Clinical Laboratory Evaluations Reported as TEAEs
Description
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.
Time Frame
From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)
Title
Number of Participants With Abnormal Vital Signs Reported as TEAEs
Description
Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, respiration rate, heart rate, pulse oximetry, and body temperature.
Time Frame
From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)
Title
Number of Participants With Abnormal Electrocardiogram Reported as TEAEs
Description
Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.
Time Frame
From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol (HDL-C)
Description
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol.
Time Frame
Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol Ester (HDL-CE)
Description
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol ester.
Time Frame
Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Cholesterol Ester
Description
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of cholesterol ester.
Time Frame
Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.
Secondary Outcome Measure Information:
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein A1
Description
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein A1.
Time Frame
Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Low-density Lipoprotein Cholesterol (LDL-C).
Description
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of LDL-C.
Time Frame
Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.
Title
Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein B
Description
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein B.
Time Frame
Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.
Title
Change From Baseline in Serum Concentration for MEDI6012 Mass
Description
The trough concentration level of MEDI6012 following each dose is reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).
Time Frame
Seven days post-dose following Doses 1 to 3 in Cohorts 1 to 3 and placebo arm (Days 8, 15, 22); 2 days post-dose following Dose 1 (Day 3) and 7 days post-dose following Doses 2 and 3 (Days 10, 17) in Cohort 4 and placbo IV push.
Title
Change From Baseline in Serum Concentration for Total LCAT Activity
Description
Lecithin-cholesterol acyltransferase (LCAT) is a plasma enzyme secreted by the liver. Serum LCAT activity was estimated to provide an alternative measure to LCAT mass in establishing the relationship between pharmacokinetics and pharmacodynamics of MEDI6012. Change in LCAT activity from baseline (pre-dose of each dose) to post doses was reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).
Time Frame
Seven days post-dose following Doses 1 to 3 in Cohorts 1 to 3 and placebo arm (Days 8, 15, 22); 2 days post-dose following Dose 1 (Day 3) and 7 days post-dose following Doses 2 and 3 (Days 10, 17) in Cohort 4 and placbo IV push.
Title
Maximum Observed Serum Concentration (Cmax) of MEDI6012
Description
The maximum observed serum concentration following the first and third dose of MEDI6012 was reported.
Time Frame
Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; Cmax following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of MEDI6012
Description
The time to reach the maximum observed serum concentration following the first and third dose of MEDI6012 was reported.
Time Frame
Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; Tmax following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.
Title
Accumulation Ratio (Rac) of MEDI6012
Description
The accumulation ratio (Rac) is defined as the ratio of accumulation of a study drug going from a single dose to steady state with repeated administration. Accumulation ratio was reported on the basis of maximum concentration (ARC max) and area under the concentration-time curve (ARAUC).
Time Frame
Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; The Rac following third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.
Title
Terminal Half-life (t1/2) of MEDI6012
Description
The t1/2 is the time measured for the serum concentration to decrease by one half after the third dose of MEDI6012.
Time Frame
The t1/2 following third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.
Title
Area Under the Concentration Time Curve to Last Measurable Time Point (AUClast) of MEDI6012
Description
The area under the concentration time-curve to the last measured concentration after the third dose of MEDI6012 was reported.
Time Frame
Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; AUClast following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.
Title
Number of Participants With Positive Anti-Drug Antibodies for MEDI6012
Description
Participants with positive serum antibodies to MEDI6012 were reported.
Time Frame
For Cohorts 1 to 3 and Placebo arm: Pre-dose on Days 1 and 15, and on Days 29, 43, and 71; For Cohort 4 and Placebo IV push arm: Pre-dose on Days 1 and 10, and on Days 24, 38, and 66.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-childbearing potential
Diagnosis of stable atherosclerotic CVD
Currently receiving a stable dose of Statin
Exclusion Criteria:
Unstable cardiovascular condition within 3 months of screening
Elective arterial revascularization with in the past month
Any planned arterial revascularization
Body mass index <18 or >45
Clinically significant ECG that may interfere with the interpretation of serial ECG and QT interval changes at screening
Chronic kidney disease defined by estimated glomerular filtration rate of less than 30 mL/mim/1.73m2
Triglycerides greater than 500 mg/dL, LDL-C greater than 160 mg/dL, or HDL-C greater than 60 for males, or 65 for females
Clinically significant vital sign abnormalities
Genetic disorder of cholesterol metabolism
History of overt liver disease
Poorly controlled endocrine disorder (Diabetes or Thyroid disorder)
Current or recent use of systemic corticosteroids
Recent or ongoing infection or febrile illness
History of active malignancy within 5 years
History of alcohol or recreational substance abuse in the past 6 months
Concurrent enrollment in another clinical study of any investigational drug therapy or use of any biologicals within 6 months prior to screening or within 5 half-lives of an investigational agent or biologic, whichever is longer.
Facility Information:
Facility Name
Research Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4211&filename=D5780C00005-CSP-amendment-1_REDACTED_16Jul2017_PDF-A.pdf
Description
D5780C00005-CSP-amendment-1_REDACTED_16Jul2017_PDF-A
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4211&filename=5780C00005%20MEDI6012%20Statistical%20Analysis%20Plan_21Jul2017_Version2_Redacted_PDF-A.pdf
Description
5780C00005 MEDI6012 Statistical Analysis Plan_21Jul2017_Version2_Redacted_PDF-A.pdf
Learn more about this trial
Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease
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