Back to resultsMK-0524B Lipid Study (MK-0524B-063)
Primary Purpose
Primary Hypercholesterolemia, Mixed Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: simvastatin
MK-0524A
Placebo
MK-0524B
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- has primary hypercholesterolemia or mixed dyslipidemia based on medical history (previous diagnosis), historic lipid values, or as otherwise determined through optional lipid measurements at screening visit
meets one of the following triglyceride (TG) criteria:
- is on niacin, statin, or fibrate and has TG <500 mg/dL at or within 6 months of washout
- is not on any lipid altering therapy or is on lipid altering therapy other than niacin, statin, or fibrate and has TG <600 mg/dL at or within 6 months of screening
Exclusion Criteria:
- is high risk (coronary heart disease [CHD] or CHD risk equivalent) AND is on a statin
- is pregnant or breast-feeding, or expecting to conceive during the study including the 14-day post study follow-up
- has Type 1 or Type 2 diabetes mellitus and is on statin therapy, is poorly controlled, is newly diagnosed (within 3 months of Visit 1), has recently experienced repeated hypoglycemia or unstable glycemic control or is taking new or recently adjusted anti-diabetic medications (with the exception of +/- 10 units of insulin) within 3 months of Visit 1
- has the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, human immunodeficiency virus (HIV) positive, gout (within 1 year)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg
Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg
Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg
Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg
Arm Description
After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
Outcomes
Primary Outcome Measures
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.
Secondary Outcome Measures
Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.
Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)
Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST ULNs for males and females were 43 U/L and 36 U/L, respectively. The ALT ULNs for males and females were 40 U/L and 33 U/L, respectively.
Percentage of Participants With Creatine Kinase (CK) >=10 x ULN
Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.
Percentage of Participants With CK >=10 x ULN With Muscle Symptoms
Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.
Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related
Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.
Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose
Participants had fasting glucose levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became 'impaired' during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.
Percentage of Participants With New Diagnosis of Diabetes
Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.
Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline
Participants with diabetes at baseline and who experienced a worsening of the diabetes identified through adverse event reports using a pre-defined set of terms and/or increasing dose/adding a new anti-diabetic medication.
Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event
Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee as cardiovascular events were recorded
Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.
Percentage of Participants Who Experience at Least 1 Laboratory AE
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test
Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.
Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.
Percentage of Participants Who Experience at Least 1 Hepatitis-related Non-serious Clinical AE
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Non-serious Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.
Percentage Change From Baseline in LDL-C at Week 4
Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the LDL-C levels. The change from baseline after 4 weeks of treatment was recorded.
Percentage Change From Baseline in HDL-C at Week 4
Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the HDL-C levels. The change from baseline after 4 weeks of treatment was recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00479882
Brief Title
MK-0524B Lipid Study (MK-0524B-063)
Official Title
A Multicenter, Randomized, Double-Blind, "Crossover" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet Compared to MK-0524A + Simvastatin Coadministration in Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2007 (Actual)
Primary Completion Date
June 16, 2008 (Actual)
Study Completion Date
June 16, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 20-week clinical trial in participants with primary hypercholesterolemia or mixed dyslipidemia to demonstrate the effect of MK-0524B compared to MK-0524A + Simvastatin on lipid values.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia, Mixed Dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2414 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg
Arm Type
Experimental
Arm Description
After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
Arm Title
Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg
Arm Type
Experimental
Arm Description
After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
Arm Title
Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg
Arm Type
Experimental
Arm Description
After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
Arm Title
Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg
Arm Type
Experimental
Arm Description
After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Comparator: simvastatin
Other Intervention Name(s)
Zocor®, MK0733
Intervention Type
Drug
Intervention Name(s)
MK-0524A
Intervention Description
Extended-release(ER) niacin/Laropiprant (MK-0524) Combination tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
MK-0524B
Primary Outcome Measure Information:
Title
Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Description
Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the LDL-C levels. The change from baseline after 8 weeks of treatment was recorded.
Time Frame
Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)
Secondary Outcome Measure Information:
Title
Percentage Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)
Description
Blood samples taken at baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period to determine the HDL-C levels. The change from baseline after 8 weeks of treatment was recorded.
Time Frame
Baseline (Week 4 for Period II; Week 12 for Period III) and after 8 weeks of treatment during each period (Week 12 for Period II and Week 20 for Period III)
Title
Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x Upper Limit of Normal (ULN)
Description
Participants had AST and ALT levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of either AST or ALT that was 3 x ULN or greater were recorded. The AST ULNs for males and females were 43 U/L and 36 U/L, respectively. The ALT ULNs for males and females were 40 U/L and 33 U/L, respectively.
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage of Participants With Creatine Kinase (CK) >=10 x ULN
Description
Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage of Participants With CK >=10 x ULN With Muscle Symptoms
Description
Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage of Participants With CK >=10 x ULN With Muscle Symptoms - Drug Related
Description
Participants had CK levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had an assessment of CK that was 10 x ULN or greater and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The ULNs for males and females were 207 U/L and 169 U/L, respectively.
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose
Description
Participants had fasting glucose levels assessed during Period I (4 weeks ) throughout each 8 week treatment period (20 weeks total). Participants who had the new diagnosis of impaired fasting blood glucose were recorded. A pre-defined set of MedDRA terms was used to identify participants whose glycemic status became 'impaired' during the course of treatment (from clinical adverse experience reports). The MedDRA terms were as follows: blood glucose increased, blood glucose abnormal, glucose tolerance decreased, glucose tolerance test abnormal, carbohydrate tolerance decreased, glucose tolerance impaired, hyperglycaemia, impaired fasting glucose, impaired insulin secretion, metabolic syndrome, insulin resistance, insulin resistance syndrome.
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage of Participants With New Diagnosis of Diabetes
Description
Participants who with newly diagnosed of diabetes were recorded. A participant was classified as having new onset diabetes if they experienced an adverse Event (AE) related to a diagnosis of diabetes (based on a pre-defined set of Medical Dictionary for Regulatory Activities [MedDRA] terms), or if they started taking an anti-diabetic medication during the course of the study. The MedDRA terms were as follows: diabetes mellitus, diabetes mellitus insulin-dependent, diabetes mellitus non-insulin dependent, insulin-requiring type II diabetes mellitus, insulin resistant diabetes, diabetes with hyperosmolarity, latent autoimmune diabetes in adults.
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage of Participants With Worsening of the Pre-existing Conditions of Diabetes in Participants With Diabetes at Baseline
Description
Participants with diabetes at baseline and who experienced a worsening of the diabetes identified through adverse event reports using a pre-defined set of terms and/or increasing dose/adding a new anti-diabetic medication.
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage of Participants With a Confirmed Adjudicated Cardiovascular Event
Description
Select serious adverse cardiovascular events and all-cause mortality that occurred during the treatment phase of the study were adjudicated by an expert committee external to the sponsor. Those events confirmed by the committee as cardiovascular events were recorded
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE)
Description
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant.
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage of Participants Who Experience at Least 1 Laboratory AE
Description
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage of Participants Who Were Discontinued From the Study Due to a Clinical AE
Description
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A clinical AE was an AE reported as a result of a clinical examination or reported by the participant. Participants who were discontinued from the study due to a clinical AE were recorded.
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage of Participants Who Were Discontinued From the Study Due to a Laboratory AE
Description
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test. Participants who were discontinued from the study due to a laboratory AE were recorded.
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage of Participants Who Experience at Least 1 Hepatitis-related Non-serious Clinical AE
Description
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Non-serious Hepatitis-related AEs were identified by a collective review using the following pre-specified set of preferred terms: cholestasis, hepatic necrosis, hepatocellular damage, cytolytic hepatitis, hepatitis, hepatomegaly, jaundice, hepatic failure, hepatitis cholestatic, jaundice cholestatic, hepatitis fulminant, hyperbilirubinaemia, jaundice hepatocellular, ocular icterus, yellow skin, hepatic function abnormal, acute hepatic failure, subacute hepatic failure, hepatitis acute, hepatitis toxic, hepatotoxicity, and mixed hepatocellular-cholestatic injury.
Time Frame
up 20 weeks (12 weeks in Period I/II and 8 weeks in Period III)
Title
Percentage Change From Baseline in LDL-C at Week 4
Description
Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the LDL-C levels. The change from baseline after 4 weeks of treatment was recorded.
Time Frame
Baseline (Day1 of Period I) and Week 4
Title
Percentage Change From Baseline in HDL-C at Week 4
Description
Blood samples taken at baseline (Day1 of Period I) and after 4 weeks of treatment to determine the HDL-C levels. The change from baseline after 4 weeks of treatment was recorded.
Time Frame
Baseline (Day1 of Period I) and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
has primary hypercholesterolemia or mixed dyslipidemia based on medical history (previous diagnosis), historic lipid values, or as otherwise determined through optional lipid measurements at screening visit
meets one of the following triglyceride (TG) criteria:
is on niacin, statin, or fibrate and has TG <500 mg/dL at or within 6 months of washout
is not on any lipid altering therapy or is on lipid altering therapy other than niacin, statin, or fibrate and has TG <600 mg/dL at or within 6 months of screening
Exclusion Criteria:
is high risk (coronary heart disease [CHD] or CHD risk equivalent) AND is on a statin
is pregnant or breast-feeding, or expecting to conceive during the study including the 14-day post study follow-up
has Type 1 or Type 2 diabetes mellitus and is on statin therapy, is poorly controlled, is newly diagnosed (within 3 months of Visit 1), has recently experienced repeated hypoglycemia or unstable glycemic control or is taking new or recently adjusted anti-diabetic medications (with the exception of +/- 10 units of insulin) within 3 months of Visit 1
has the following conditions: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, human immunodeficiency virus (HIV) positive, gout (within 1 year)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
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
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis Link
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=0524B-063&kw=0524B-063&tab=access
Learn more about this trial
MK-0524B Lipid Study (MK-0524B-063)
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