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A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

Primary Purpose

Hypercholesterolemia, Familial Hypercholesterolemia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MK-0616
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change Exclusion Criteria: Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH Has a history of heart failure or heart failure hospitalization within 3 months before first study visit Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

Sites / Locations

  • Alliance for Multispecialty Research, LLC ( Site 0093)Recruiting
  • G&L Research ( Site 0043)Recruiting
  • Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)Recruiting
  • Velocity Clinical Research, Banning ( Site 0017)Recruiting
  • National Heart Institute-Research ( Site 0087)Recruiting
  • Clinical Trials Research ( Site 0115)Recruiting
  • Emerson Clinical Research Institute ( Site 0118)Recruiting
  • Excel Medical Clinical Trials ( Site 0053)Recruiting
  • Alliance for Multispecialty Research, LLC ( Site 0088)Recruiting
  • Alliance for Multispecialty Research, LLC ( Site 0094)Recruiting
  • Velocity Clinical Research, Hallandale Beach ( Site 0018)Recruiting
  • Jacksonville Center for Clinical Research ( Site 0049)Recruiting
  • South Broward Research ( Site 0051)Recruiting
  • Clinical Research Trials of Florida ( Site 0063)Recruiting
  • East Coast Institute for Research, LLC ( Site 0033)Recruiting
  • Healthcare Research Network - Chicago ( Site 0052)Recruiting
  • Synexus Clinical Research US - Evansville ( Site 0109)Recruiting
  • Midwest Institute For Clinical Research ( Site 0059)Recruiting
  • Alliance for Multispecialty Research, LLC ( Site 0028)Recruiting
  • L-MARC Research Center ( Site 0001)Recruiting
  • Velocity Clinical Research, Slidell ( Site 0068)Recruiting
  • Meridian Clinical Research, LLC ( Site 0082)Recruiting
  • Velocity Clinical Research, Gulfport ( Site 0039)Recruiting
  • Healthcare Research Network - St. Louis ( Site 0054)Recruiting
  • Jubilee Clinical Research ( Site 0106)Recruiting
  • AB Clinical Trials ( Site 0070)Recruiting
  • New Mexico Clinical Research & Osteoporosis Center ( Site 0005)Recruiting
  • Velocity Clinical Research, Syracuse ( Site 0021)Recruiting
  • Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002)Recruiting
  • Lillestol Research ( Site 0026)Recruiting
  • altoona center for clinical research ( Site 0089)Recruiting
  • Cardiology Consultants of Philadelphia Yardley ( Site 0097)Recruiting
  • Piedmont Research Partners ( Site 0090)Recruiting
  • Velocity Clinical Research, Greenville ( Site 0023)Recruiting
  • Coastal Carolina Research Center ( Site 0006)Recruiting
  • Holston Medical Group ( Site 0048)Recruiting
  • Alliance for Multispecialty Research, LLC ( Site 0008)Recruiting
  • Velocity Clinical Research, Dallas ( Site 0114)Recruiting
  • Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111)Recruiting
  • Clinical Trials of Texas, LLC ( Site 0103)Recruiting
  • Synexus Clinical Research US, Inc. ( Site 0110)Recruiting
  • Velocity Clinical Research, Salt Lake City ( Site 0019)Recruiting
  • Manassas Clinical Research Center ( Site 0007)Recruiting
  • Health Research of Hampton Roads, Inc. ( Site 0044)Recruiting
  • Alliance for Multispecialty Research, LLC ( Site 0101)Recruiting
  • National Clinical Research, Inc ( Site 0061)Recruiting
  • Centricity Research Suffolk Primary Care ( Site 0092)Recruiting
  • Rainier Clinical Research Center ( Site 0116)Recruiting
  • CEDIC ( Site 0612)Recruiting
  • Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 0620)Recruiting
  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0605)Recruiting
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0604)Recruiting
  • Fundación Respirar ( Site 0610)Recruiting
  • Rambam Health Care Campus-internal department ( Site 1718)Recruiting
  • Hadassah Medical Center ( Site 1709)Recruiting
  • Sheba Medical Center ( Site 1708)Recruiting
  • Yitzhak Shamir Medical Center ( Site 1712)Recruiting
  • Hirohata Naika Clinic ( Site 3513)Recruiting
  • Nakakinen clinic ( Site 3510)Recruiting
  • Noritake Clinic ( Site 3512)Recruiting
  • National Hospital Organization Kanazawa Medical Center ( Site 3508)Recruiting
  • Hirano Medical Clinic ( Site 3522)Recruiting
  • Shirai Healthcare Clinic Izumichuou ( Site 3527)Recruiting
  • Rinku General Medical Center ( Site 3503)Recruiting
  • Shiraiwa Medical Clinic ( Site 3514)Recruiting
  • Medical Corporation Heishinkai OCROM Clinic ( Site 3501)Recruiting
  • Saitama Medical University Hospital ( Site 3506)Recruiting
  • Teramoto Medical and Dental Clinic ( Site 3507)Recruiting
  • Tokyo-Eki Center-building Clinic ( Site 3505)Recruiting
  • Fukuwa Clinic ( Site 3504)Recruiting
  • Kato Clinic of Internal Medicine ( Site 3509)Recruiting
  • Kanno Naika ( Site 3511)Recruiting
  • Sugawara Clinic ( Site 3519)Recruiting
  • Shin Clinic - Tokyo - Nishikamata ( Site 3517)Recruiting
  • Heishinkai Medical Group ToCROM Clinic ( Site 3502)Recruiting
  • Mitsukoshi Health and Welfare Foundation ( Site 3521)Recruiting
  • Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)Recruiting
  • Mishuku Hospital ( Site 3524)Recruiting
  • Chungbuk National University Hospital ( Site 3011)Recruiting
  • Wonju Severance Christian Hospital ( Site 3008)Recruiting
  • Chonnam National University Hospital ( Site 3014)Recruiting
  • Seoul National University Bundang Hospital ( Site 3005)Recruiting
  • Ajou University Hospital ( Site 3006)Recruiting
  • Dong-A University Hospital ( Site 3013)Recruiting
  • Pusan National University Hospital-Internal Medicine ( Site 3012)Recruiting
  • Inje University Haeundae Paik Hospital ( Site 3010)Recruiting
  • Keimyung University Dongsan Hospital ( Site 3003)Recruiting
  • Seoul National University Hospital ( Site 3001)Recruiting
  • Kangbuk Samsung Hospital ( Site 3009)Recruiting
  • Severance Hospital, Yonsei University Health System ( Site 3002)Recruiting
  • Asan Medical Center ( Site 3004)Recruiting
  • Samsung Medical Center-cardiology ( Site 3000)Recruiting
  • The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)Recruiting
  • Changhua Christian Hospital ( Site 3101)Recruiting
  • National Taiwan University Hospital ( Site 3100)Recruiting
  • Taipei Medical University Hospital-Cardiology ( Site 3108)Recruiting
  • Taipei Veterans General Hospital ( Site 3106)Recruiting
  • Hacettepe Universite Hastaneleri ( Site 2500)Recruiting
  • Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)Recruiting
  • Eskisehir Osmangazi University-Cardiology ( Site 2510)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MK-0616

Placebo

Arm Description

Participants will receive 20 mg of MK-0616 orally once daily (QD) for up to 52 weeks.

Participants will receive MK-0616-matching placebo orally QD for up to 52 weeks.

Outcomes

Primary Outcome Measures

Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
Number of participants with one or more adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants who discontinue study drug due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Secondary Outcome Measures

Mean percent change from baseline in LDL-C at Week 52
Blood samples will be collected at baseline and at Week 52 to assess mean percent change in LDL-C.
Mean percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.
Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.
Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24
Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a).
Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24
Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline.
Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24
Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline.

Full Information

First Posted
July 10, 2023
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05952856
Brief Title
A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
September 15, 2025 (Anticipated)
Study Completion Date
September 24, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this study is to evaluate the efficacy, safety, and tolerability of MK-0616 in adult participants with hypercholesterolemia. The primary hypothesis is that MK-0616 is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Familial Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2760 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MK-0616
Arm Type
Experimental
Arm Description
Participants will receive 20 mg of MK-0616 orally once daily (QD) for up to 52 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive MK-0616-matching placebo orally QD for up to 52 weeks.
Intervention Type
Drug
Intervention Name(s)
MK-0616
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24
Description
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in LDL-C.
Time Frame
Baseline and Week 24
Title
Number of participants with one or more adverse events (AEs)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
Up to ~60 weeks
Title
Number of participants who discontinue study drug due to an AE
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time Frame
Up to ~52 weeks
Secondary Outcome Measure Information:
Title
Mean percent change from baseline in LDL-C at Week 52
Description
Blood samples will be collected at baseline and at Week 52 to assess mean percent change in LDL-C.
Time Frame
Baseline and Week 52
Title
Mean percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 24
Description
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in non-HDL-C.
Time Frame
Baseline and Week 24
Title
Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24
Description
Blood samples will be collected at baseline and at Week 24 to assess mean percent change in ApoB.
Time Frame
Baseline and Week 24
Title
Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24
Description
Blood samples will be collected at baseline and at Week 24 to assess percent change in Lp(a).
Time Frame
Baseline and Week 24
Title
Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline at Week 24
Description
Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <70 mg/dL and ≥50% reduction from baseline.
Time Frame
Baseline and Week 24
Title
Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline at Week 24
Description
Blood samples will be collected at baseline and at Week 24 to assess the percentage of participants who have LDL-C <55 mg/dL and ≥50% reduction from baseline.
Time Frame
Baseline and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a history of a major atherosclerotic cardiovascular disease (ASCVD) event and LDL-C ≥55 mg/dL OR, if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event and LDL-C ≥70 mg/dL Is treated with a moderate- or high-intensity statin OR is treated with low-intensity statin with documentation of intolerance to a moderate or high-intensity statin OR is not receiving statins with documentation of statin intolerance If on any lipid-lowering therapies (LLTs), should be on a stable dose with no planned medication change Exclusion Criteria: Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH Has a history of heart failure or heart failure hospitalization within 3 months before first study visit Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0093)
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
615-591-0211
Facility Name
G&L Research ( Site 0043)
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
251-943-2980
Facility Name
Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0084)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
602-200-3814
Facility Name
Velocity Clinical Research, Banning ( Site 0017)
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
951-755-0223
Facility Name
National Heart Institute-Research ( Site 0087)
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-289-5221
Facility Name
Clinical Trials Research ( Site 0115)
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
916-434-8230
Facility Name
Emerson Clinical Research Institute ( Site 0118)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
202-239-0777
Facility Name
Excel Medical Clinical Trials ( Site 0053)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
561-756-8206
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0088)
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
615-591-0211
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0094)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
888-259-1231
Facility Name
Velocity Clinical Research, Hallandale Beach ( Site 0018)
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
954-455-5757
Facility Name
Jacksonville Center for Clinical Research ( Site 0049)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
904-730-0101
Facility Name
South Broward Research ( Site 0051)
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
954-433-5867
Facility Name
Clinical Research Trials of Florida ( Site 0063)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
813-873-8102
Facility Name
East Coast Institute for Research, LLC ( Site 0033)
City
Macon
State/Province
Georgia
ZIP/Postal Code
31210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
478-219-2017
Facility Name
Healthcare Research Network - Chicago ( Site 0052)
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
708-388-2245
Facility Name
Synexus Clinical Research US - Evansville ( Site 0109)
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
812-477-2760
Facility Name
Midwest Institute For Clinical Research ( Site 0059)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
317-705-7070
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0028)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
859-264-8999
Facility Name
L-MARC Research Center ( Site 0001)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
502-515-5672
Facility Name
Velocity Clinical Research, Slidell ( Site 0068)
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
985-259-7002
Facility Name
Meridian Clinical Research, LLC ( Site 0082)
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
240-698-2800
Facility Name
Velocity Clinical Research, Gulfport ( Site 0039)
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
228-206-1283
Facility Name
Healthcare Research Network - St. Louis ( Site 0054)
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
314-972-9600
Facility Name
Jubilee Clinical Research ( Site 0106)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
702-631-5000
Facility Name
AB Clinical Trials ( Site 0070)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
702-233-4700
Facility Name
New Mexico Clinical Research & Osteoporosis Center ( Site 0005)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
505-923-3232
Facility Name
Velocity Clinical Research, Syracuse ( Site 0021)
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
315-760-5905
Facility Name
Icahn School of Medicine at Mount Sinai-Cardiology ( Site 0002)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
212-241-9101
Facility Name
Lillestol Research ( Site 0026)
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
701-232-7705
Facility Name
altoona center for clinical research ( Site 0089)
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
814-693-0300
Facility Name
Cardiology Consultants of Philadelphia Yardley ( Site 0097)
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
215-321-7400
Facility Name
Piedmont Research Partners ( Site 0090)
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
803-802-4561
Facility Name
Velocity Clinical Research, Greenville ( Site 0023)
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
864-901-8077
Facility Name
Coastal Carolina Research Center ( Site 0006)
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
843-856-3784
Facility Name
Holston Medical Group ( Site 0048)
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
423-578-1578
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0008)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
865-305-9100
Facility Name
Velocity Clinical Research, Dallas ( Site 0114)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
682-348-1258
Facility Name
Center for Cardiometabolic Disease Prevention/Baylor College of Medicine ( Site 0111)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
713-798-5800
Facility Name
Clinical Trials of Texas, LLC ( Site 0103)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
210-949-0122
Facility Name
Synexus Clinical Research US, Inc. ( Site 0110)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
801-261-8930
Facility Name
Velocity Clinical Research, Salt Lake City ( Site 0019)
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
801-542-8190
Facility Name
Manassas Clinical Research Center ( Site 0007)
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
703-330-1112
Facility Name
Health Research of Hampton Roads, Inc. ( Site 0044)
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
757-591-8100
Facility Name
Alliance for Multispecialty Research, LLC ( Site 0101)
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
757-627-7446
Facility Name
National Clinical Research, Inc ( Site 0061)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
804-755-2300
Facility Name
Centricity Research Suffolk Primary Care ( Site 0092)
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
757-538-7553
Facility Name
Rainier Clinical Research Center ( Site 0116)
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
425-251-1720
Facility Name
CEDIC ( Site 0612)
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1060ABN
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
541148236838
Facility Name
Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 0620)
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1027AAP
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5491165496764
Facility Name
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0605)
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZO
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
552234963224
Facility Name
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0604)
City
Ciudad Autonoma de Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1425AGC
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
541148019001
Facility Name
Fundación Respirar ( Site 0610)
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
54911 4193 8318
Facility Name
Rambam Health Care Campus-internal department ( Site 1718)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97248543097
Facility Name
Hadassah Medical Center ( Site 1709)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972505172720
Facility Name
Sheba Medical Center ( Site 1708)
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
97235304582
Facility Name
Yitzhak Shamir Medical Center ( Site 1712)
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972547914992
Facility Name
Hirohata Naika Clinic ( Site 3513)
City
Kitakyusyu-shi
State/Province
Fukuoka
ZIP/Postal Code
807-0857
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81936931511
Facility Name
Nakakinen clinic ( Site 3510)
City
Naka
State/Province
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
029-353-2800
Facility Name
Noritake Clinic ( Site 3512)
City
Ushiku
State/Province
Ibaraki
ZIP/Postal Code
300-1207
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81298717878
Facility Name
National Hospital Organization Kanazawa Medical Center ( Site 3508)
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-76-262-4161
Facility Name
Hirano Medical Clinic ( Site 3522)
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-0132
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
09053572048
Facility Name
Shirai Healthcare Clinic Izumichuou ( Site 3527)
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
981-3133
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-22-346-0886
Facility Name
Rinku General Medical Center ( Site 3503)
City
Izumisano
State/Province
Osaka
ZIP/Postal Code
598-8577
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0724693111
Facility Name
Shiraiwa Medical Clinic ( Site 3514)
City
Kashiwara
State/Province
Osaka
ZIP/Postal Code
582-0005
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0729711221
Facility Name
Medical Corporation Heishinkai OCROM Clinic ( Site 3501)
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81663308810
Facility Name
Saitama Medical University Hospital ( Site 3506)
City
Iruma
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81492761875
Facility Name
Teramoto Medical and Dental Clinic ( Site 3507)
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-0033
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81356840818
Facility Name
Tokyo-Eki Center-building Clinic ( Site 3505)
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81335176688
Facility Name
Fukuwa Clinic ( Site 3504)
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3-6262-3751
Facility Name
Kato Clinic of Internal Medicine ( Site 3509)
City
Katsushika-ku
State/Province
Tokyo
ZIP/Postal Code
125-0054
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
Kanno Naika ( Site 3511)
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-0013
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0422-40-5022
Facility Name
Sugawara Clinic ( Site 3519)
City
Nerima-ku
State/Province
Tokyo
ZIP/Postal Code
177-0041
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81339963016
Facility Name
Shin Clinic - Tokyo - Nishikamata ( Site 3517)
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
144-0051
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81337381112
Facility Name
Heishinkai Medical Group ToCROM Clinic ( Site 3502)
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81353665333
Facility Name
Mitsukoshi Health and Welfare Foundation ( Site 3521)
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
03-3348-5791
Facility Name
Medical Corporation Hakuaikai Wellness Tenjin Clinic ( Site 3520)
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
81-92-738-3335
Facility Name
Mishuku Hospital ( Site 3524)
City
Tokyo
ZIP/Postal Code
153-0051
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-3711-5771
Facility Name
Chungbuk National University Hospital ( Site 3011)
City
Cheongju-si
State/Province
Chungbuk
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82432696011
Facility Name
Wonju Severance Christian Hospital ( Site 3008)
City
Wonju
State/Province
Kang-won-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82337410910
Facility Name
Chonnam National University Hospital ( Site 3014)
City
Gwangju-si
State/Province
Kwangju-Kwangyokshi
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82622206243
Facility Name
Seoul National University Bundang Hospital ( Site 3005)
City
Seongnam
State/Province
Kyonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
01097001676
Facility Name
Ajou University Hospital ( Site 3006)
City
Suwon
State/Province
Kyonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82-31-219-5719
Facility Name
Dong-A University Hospital ( Site 3013)
City
Busan
State/Province
Pusan-Kwangyokshi
ZIP/Postal Code
49201
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82-51-240-2976
Facility Name
Pusan National University Hospital-Internal Medicine ( Site 3012)
City
Busan
State/Province
Pusan-Kwangyokshi
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82512407794
Facility Name
Inje University Haeundae Paik Hospital ( Site 3010)
City
Haeundae-gu
State/Province
Pusan-Kwangyokshi
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-10-4552-6987
Facility Name
Keimyung University Dongsan Hospital ( Site 3003)
City
Daegu
State/Province
Taegu-Kwangyokshi
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82535807719
Facility Name
Seoul National University Hospital ( Site 3001)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
821076443354
Facility Name
Kangbuk Samsung Hospital ( Site 3009)
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
821026636943
Facility Name
Severance Hospital, Yonsei University Health System ( Site 3002)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82-10-5472-6911
Facility Name
Asan Medical Center ( Site 3004)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82-10-2731-2035
Facility Name
Samsung Medical Center-cardiology ( Site 3000)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82-2-3410-3410
Facility Name
The Catholic Univ. of Korea Seoul St. Mary's Hospital-cardiology ( Site 3007)
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
82-10-2593-1635
Facility Name
Changhua Christian Hospital ( Site 3101)
City
Changhua County
State/Province
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886-917-150-696
Facility Name
National Taiwan University Hospital ( Site 3100)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
88622312345665350
Facility Name
Taipei Medical University Hospital-Cardiology ( Site 3108)
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
886-2737-2181ext8603
Facility Name
Taipei Veterans General Hospital ( Site 3106)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+886938590796
Facility Name
Hacettepe Universite Hastaneleri ( Site 2500)
City
Altindağ
State/Province
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905068465583
Facility Name
Ankara Bilkent Şehir Hastanesi-cardiology ( Site 2501)
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
90 533 236 10 07
Facility Name
Eskisehir Osmangazi University-Cardiology ( Site 2510)
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
905332337849

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
http://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=0616-013&kw=0616-013
Description
Plain Language Summary

Learn more about this trial

A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-013) CORALreef Lipids

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