Clinical Trial: Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Percentage Change From Baseline in the LDL-C/HDL-C Ratio [ Time Frame: Baseline and Week 12 ]
Original Primary Outcome: Change in LDL-C/HDL-C
Current Secondary Outcome:
- 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 presen
Original Secondary Outcome: Change in other lipid parameters
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: February 7, 2006
Date Started: January 2006
Date Completion:
Last Updated: March 3, 2017
Last Verified: March 2017
