Niacin (+) Laropiprant (TREDAPTIVE) Re-examination Study (MK-0524A-119)

NCT01228019 | Terminated Results

• 1 other identifier: 0524A-119
• Study Type: observational
• Target: 1,166
• Locations: 0 countries
• Sites: N/A

Brief Summary

This survey is being conducted to assess the safety and efficacy of niacin (+) laropiprant (TREDAPTIVE) in usual practice in Korea according to the new product re-examination regulations of the Korean Food and Drug Administration.

Conditions

Hypercholesterolemia; Mixed Dyslipidemia

Keywords

Usual practice re-examination

Outcome Measures

Primary Outcomes (12)

• Percentage of Participants With Any Adverse Experience

  An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, 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 study drug, was also an adverse event.

  From start of treatment through 14 days after the last dose (Up to 26 weeks)

• Percentage of Participants With Adverse Drug Reactions

  An adverse drug reaction was an adverse event of which the relationship to the study drug could not be ruled out. An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, 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 study drug, was also an adverse event.

  From start of treatment through 14 days after the last dose (Up to 26 weeks)

• Change From Baseline in Total Cholesterol at Week 12

  Serum cholesterol levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE

  Baseline and Week 12

• Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

  Serum LDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE

  Baseline and Week 12

• Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12

  Serum HDL-C levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE

  Baseline and Week 12

• Change From Baseline in Triglycerides at Week 12

  Serum triglyceride levels were measured at start of treatment (baseline) and after 12 weeks of treatment with TREDAPTIVE

  Baseline and Week 12

• Change From Baseline in Total Cholesterol at Week 24

  Serum cholesterol levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE

  Baseline and Week 24

• Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24

  Serum LDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE

  Baseline and Week 24

• Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24

  Serum HDL-C levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE

  Baseline and Week 24

• Change From Baseline in Triglycerides at Week 24

  Serum triglyceride levels were measured at start of treatment (baseline) and after 24 weeks of treatment with TREDAPTIVE

  Baseline and Week 24

• Investigator's Overall Efficacy Evaluation at Week 12

  The investigator evaluated all available data after 12 weeks of TREDAPTIVE and assigned an overall evaluation of "Improved", "Unchanged" or "Worsened" when compared to baseline.

  Baseline and Week 12

• Investigator's Overall Efficacy Evaluation at Week 24

  The investigator evaluated all available data after 24 weeks of TREDAPTIVE and assigned an overall evaluation of "Improved", "Unchanged" or "Worsened" when compared to baseline.

  Baseline and Week 24

Study Arms (1)

All participants

Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)

Drug: Niacin (+) laropiprant

Interventions

Niacin (+) laropiprant DRUG

Niacin (+) laropiprant (TREDAPTIVE) prescribed according to the current local label

Also known as: MK-0524A

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Korean participants with hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE) for the first time

You may qualify if:

• Participants who are treated with TREDAPTIVE tablet within current local label for the first time
• Participants with primary hypercholesterolemia or mixed dyslipidemia
• Participants who are treated with TREDAPTIVE for more than or equal to 24 weeks will be included in long-term surveillance
• Special participants with known hepatic disorder or renal disorder, participants 65 years old or older, participants younger than 19 years old, and pregnant woman will be evaluated if collected.

You may not qualify if:

• Participant who is treated with TREDAPTIVE tablet before contract and out of enrollment period
• Participant who has a contraindication to TREDAPTIVE tablet according to the current local label

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Niacin; MK-0524

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Study enrollment stopped early due to termination of all TREDAPTIVE studies. Data obtained for participants enrolled prior to termination was analyzed and reported.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 25, 2010
• Study Start: December 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 21, 2015
• Results First Posted: April 25, 2014

Record last verified: 2015-04