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Trial record 3 of 3 for:    "Lipid Storage Disease" | "Atorvastatin"

Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)

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ClinicalTrials.gov Identifier: NCT00289900
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : January 26, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE February 7, 2006
First Posted Date  ICMJE February 10, 2006
Results First Submitted Date  ICMJE December 17, 2015
Results First Posted Date  ICMJE January 26, 2016
Last Update Posted Date August 31, 2018
Actual Study Start Date  ICMJE January 24, 2006
Actual Primary Completion Date August 6, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2015)
Percentage Change From Baseline in the LDL-C/HDL-C Ratio [ Time Frame: Baseline and Week 12 ]
Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C and HDL-C levels. The LDL-C/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 was recorded.
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2006)
Change in LDL-C/HDL-C
Change History Complete list of historical versions of study NCT00289900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2015)
  • Percentage Change From Baseline in HDL-C [ Time Frame: Baseline and Week 12 ]
    Blood samples taken at baseline and after 12 weeks of treatment to determine the HDL-C levels. The change from baseline at Week 12 was recorded.
  • Percentage Change From Baseline in Triglycerides (TG) [ Time Frame: Baseline and Week 12 ]
    Blood samples taken at baseline and after 12 weeks of treatment to determine the TG levels. The change from baseline at Week 12 was recorded.
  • Percentage Change From Baseline in Non-HDL-C [ Time Frame: Baseline and Week 12 ]
    Blood samples taken at baseline and after 12 weeks of treatment to determine the non-HDL-C levels. The change from baseline at Week 12 was recorded.
  • Percentage Change From Baseline in LDL-C [ Time Frame: Baseline and Week 12 ]
    Blood samples taken at baseline and after 12 weeks of treatment to determine the LDL-C levels. The change from baseline at Week 12 was recorded.
  • Percentage Change From Baseline in Apolipoprotein (Apo) B [ Time Frame: Baseline and Week 12 ]
    Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo B levels. The change from baseline at Week 12 was recorded.
  • Percentage Change From Baseline in Apo A-I [ Time Frame: Baseline and Week 12 ]
    Blood samples taken at baseline and after 12 weeks of treatment to determine the Apo A-I levels. The change from baseline at Week 12 was recorded.
  • Percentage Change From Baseline in Total Cholesterol (TC) [ Time Frame: Baseline and Week 12 ]
    Blood samples taken at baseline and after 12 weeks of treatment to determine the TC levels. The change from baseline at Week 12 was recorded.
  • Percentage Change From Baseline in Lipoprotein (a) (Lp[a]) [ Time Frame: Baseline and Week 12 ]
    Blood samples taken at baseline and after 12 weeks of treatment to determine the Lp(a) levels. The change from baseline at Week 12 was recorded.
  • Percentage Change From Baseline in C-reactive Protein (CRP) [ Time Frame: Baseline and Week 12 ]
    Blood samples taken at baseline and after 12 weeks of treatment to determine the CRP levels. The change from baseline at Week 12 was recorded.
  • Percentage Change From Baseline in TC/HDL-C Ratio [ Time Frame: Baseline and Week 12 ]
    Blood samples taken at baseline and after 12 weeks of treatment to determine the TC and HDL-C levels. The TC/HDL-C ratio was then calculated for baseline and Week 12 and the change from baseline at Week 12 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) [ Time Frame: up to 12 weeks ]
    Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.
  • Percentage of Participants With Elevations in ALT and/or AST of >=5 x ULN [ Time Frame: up to 12 weeks ]
    Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of either AST or ALT that was 5 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.
  • Percentage of Participants With Elevations in ALT and/or AST of >=10 x ULN [ Time Frame: up to 12 weeks ]
    Participants had AST and ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of either AST or ALT that was 10 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.
  • Percentage of Participants With Creatine Kinase (CK) >=10 x ULN [ Time Frame: up to 12 weeks ]
    Participants had CK assessed throughout the 12 week treatment period. Participants who had any CK level that was >=10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.
  • Percentage of Participants With CK >=10 x ULN With Muscle Symptoms [ Time Frame: up to 12 weeks ]
    Participants had CK assessed throughout the 24 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The UNLs 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 [ Time Frame: up to 12 weeks ]
    Participants had CK assessed throughout the 12 week treatment period. Participants who had any CK level that was >=10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly related to study drug were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.
  • Percentage of Participants With New Diagnosis of Impaired Fasting Blood Glucose [ Time Frame: up to 12 weeks ]
    Participants had blood glucose levels assessed throughout the 12 week treatment period. 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 [ Time Frame: up to 12 weeks ]
    Participants had blood glucose levels assessed throughout the 12 week treatment period. 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 a Confirmed Adjudicated Cardiovascular Event [ Time Frame: up to 14 weeks ]
    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 a cardiovascular events were recorded.
  • Percentage of Participants Who Experience at Least 1 Clinical Adverse Event (AE) [ Time Frame: up to 14 weeks ]
    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 Adverse Event (AE) [ Time Frame: up to 14 weeks ]
    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 [ Time Frame: up to 14 weeks ]
    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 [ Time Frame: up to 14 weeks ]
    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 Clinical AE [ Time Frame: up to 14 weeks ]
    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. 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2006)
Change in other lipid parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of MK0524B Versus Atorvastatin in Patients With Mixed Hyperlipidemia
Brief Summary This is a 12-week clinical trial in participants with mixed hyperlipidemia to study the effects of MK-0524B on lipids.The primary hypothesis is that MK-0524B (dosed as MK-0524A coadministered with simvastatin) will be superior to atorvastatin on decreasing the low denisity lipoprotein cholesterol (LDL-C)/high-density lipoprotein cholesterol (HDL-C) ratio for the following dose comparisons: 2g/20 mg MK-0524B versus 10 mg atorvastatin, 2g/40 mg MK-0524B versus 20 mg atorvastatin, 2g/40 mg MK-0524B versus 40 mg atorvastatin, and 2g/40 mg MK-0524B versus 80 mg atorvastatin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Mixed Hyperlipidemia
Intervention  ICMJE
  • Drug: MK-0524A
  • Drug: Atorvastatin
    Other Name: Lipitor
  • Drug: Simvastatin
    Other Name: Zocor
Study Arms  ICMJE
  • Experimental: MK-0524B 2g/20 mg
    Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
    Interventions:
    • Drug: MK-0524A
    • Drug: Simvastatin
  • Experimental: MK-0524B 2g/40mg
    Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
    Interventions:
    • Drug: MK-0524A
    • Drug: Simvastatin
  • Active Comparator: Atorvastatin 10 mg
    Atorvastatin 10 mg, orally, once daily for 12 weeks
    Intervention: Drug: Atorvastatin
  • Active Comparator: Atorvastatin 20 mg
    Atorvastatin 20 mg, orally, once daily for 12 weeks
    Intervention: Drug: Atorvastatin
  • Active Comparator: Atorvastatin 40 mg
    Atorvastatin 40 mg, orally, once daily for 12 weeks
    Intervention: Drug: Atorvastatin
  • Active Comparator: Atorvastatin 80 mg
    Atorvastatin 80 mg, orally, once daily for 12 weeks
    Intervention: Drug: Atorvastatin
Publications * Chen F, Maccubbin D, Yan L, Sirah W, Chen E, Sisk CM, Davidson M, Blomqvist P, McKenney JM. Lipid-altering efficacy and safety profile of co-administered extended release niacin/laropiprant and simvastatin versus atorvastatin in patients with mixed hyperlipidemia. Int J Cardiol. 2013 Jul 15;167(1):225-31. doi: 10.1016/j.ijcard.2011.12.103. Epub 2012 Feb 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2015)
2340
Original Enrollment  ICMJE
 (submitted: February 8, 2006)
1700
Actual Study Completion Date  ICMJE August 6, 2010
Actual Primary Completion Date August 6, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant 18 to 80 years of age with Mixed Hyperlipidemia with LDL-C between 130 and 190 mg/dL and Triglycerides between 150 and 500 mg/dL

Exclusion Criteria:

  • Pregnant or lactating women, or women intending to become pregnant
  • Diabetes mellitus that is poorly controlled, newly diagnosed, or taking new or recently adjusted antidiabetic therapy (with the exception of ± 10 units of insulin)
  • Human immunodeficiency virus (HIV) positive
  • Any of the following within the past 3 months: heart attack, stoke, heart bypass surgery, unstable angina, angioplasty
  • Active or chronic liver disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Chile,   Colombia,   Finland,   Guatemala,   Hong Kong,   Lithuania,   New Zealand,   Peru,   Poland,   Spain,   Sweden,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT00289900
Other Study ID Numbers  ICMJE 0524B-024
MK-0524B-024 ( Other Identifier: Merck Study Number )
2005_103
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP