Trial Outcomes & Findings for Niacin (+) Laropiprant (TREDAPTIVE) Re-examination Study (MK-0524A-119) (NCT NCT01228019)

NCT ID: NCT01228019

Last Updated: 2015-04-21

Results Overview

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.

• Recruitment status: TERMINATED
• Target enrollment: 1166 participants
• Primary outcome timeframe: From start of treatment through 14 days after the last dose (Up to 26 weeks)
• Results posted on: 2015-04-21

Participant Flow

1,166 participants who were currently using niacin (+) laropiprant (TREDAPTIVE) for treatment of primary hypercholesterolemia or mixed dyslipidemia were enrolled and their case report forms were collected. Enrollment was stopped early due to termination of all studies involving TREDAPTIVE.

A completer was considered a participant eligible for safety population. Efficacy population was a sub-population of the safety population

Participant milestones

Measure	All Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Overall Study STARTED	1166
Overall Study COMPLETED	862
Overall Study NOT COMPLETED	304

Reasons for withdrawal

Measure	All Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Overall Study Dose Violation	70
Overall Study Duplicate enrollment	1
Overall Study Missing pre-treatment data	72
Overall Study Triglyceride Entry Criteria Not Met	152
Overall Study Violation of Entry Criterion	9

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	All Participants n=862 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Age, Continuous	59.03 years STANDARD_DEVIATION 10.92 • n=5 Participants
Sex: Female, Male Female	268 Participants n=5 Participants
Sex: Female, Male Male	594 Participants n=5 Participants

PRIMARY outcome

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

Population: Safety population: all enrolled participants who met entry criteria regarding safety data

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.

Outcome measures

Measure	All Participants n=862 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Percentage of Participants With Any Adverse Experience	19.61 Percentage of participants

PRIMARY outcome

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

Population: Safety population: all enrolled participants who met entry criteria regarding safety data

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.

Outcome measures

Measure	All Participants n=862 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Percentage of Participants With Adverse Drug Reactions	15.20 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Participants in safety population whose case report form contained baseline and Week 12 data for total cholesterol levels.

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

Outcome measures

Measure	All Participants n=301 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Change From Baseline in Total Cholesterol at Week 12	-12.52 mg/dL Standard Deviation 32.44

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Participants in safety population whose case report form contained baseline and Week 12 data for LDL-C levels.

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

Outcome measures

Measure	All Participants n=274 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12	-6.81 mg/dL Standard Deviation 29.20

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Participants in safety population whose case report form contained baseline and Week 12 data for HDL-C levels.

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

Outcome measures

Measure	All Participants n=294 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12	7.06 mg/dL Standard Deviation 9.53

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Participants in safety population whose case report form contained baseline and Week 12 data for triglyceride levels.

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

Outcome measures

Measure	All Participants n=300 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Change From Baseline in Triglycerides at Week 12	-106.32 mg/dL Standard Deviation 208.38

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Participants in safety population whose case report form contained baseline and Week 24 data for total cholesterol levels and had received TREDAPTIVE for 24 weeks

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

Outcome measures

Measure	All Participants n=76 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Change From Baseline in Total Cholesterol at Week 24	-20.01 mg/dL Standard Deviation 35.08

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Participants in safety population whose case report form contained baseline and Week 24 data for LDL-C levels and had received TREDAPTIVE for 24 weeks

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

Outcome measures

Measure	All Participants n=68 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24	-14.82 mg/dL Standard Deviation 30.09

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Participants in safety population whose case report form contained baseline and Week 24 data for HDL-C levels and had received TREDAPTIVE for 24 weeks

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

Outcome measures

Measure	All Participants n=72 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24	6.25 mg/dL Standard Deviation 8.70

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Participants in safety population whose case report form contained baseline and Week 24 data for triglyceride levels and had received TREDAPTIVE for 24 weeks

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

Outcome measures

Measure	All Participants n=75 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Change From Baseline in Triglycerides at Week 24	-137.87 mg/dL Standard Deviation 153.24

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Participants in safety population whose case report form contained the investigator's overall assessment after 12 weeks of treatment with TREDAPTIVE

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.

Outcome measures

Measure	All Participants n=406 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Investigator's Overall Efficacy Evaluation at Week 12 Unchanged	25.86 Percentage of Participants
Investigator's Overall Efficacy Evaluation at Week 12 Worsened	5.91 Percentage of Participants
Investigator's Overall Efficacy Evaluation at Week 12 Improved	68.23 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: Participants in safety population whose case report form contained the investigator's overall assessment after 24 weeks of treatment with TREDAPTIVE

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.

Outcome measures

Measure	All Participants n=131 Participants Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
Investigator's Overall Efficacy Evaluation at Week 24 Improved	72.52 Percentage of Participants
Investigator's Overall Efficacy Evaluation at Week 24 Unchanged	20.61 Percentage of Participants
Investigator's Overall Efficacy Evaluation at Week 24 Worsened	6.87 Percentage of Participants

Adverse Events

ALL PARTICIPANTS

Serious events: 7 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Measure	ALL PARTICIPANTS n=862 participants at risk
Cardiac disorders ATRIAL FIBRILLATION	0.12% 1/862 • Number of events 1 • From start of treatment through 14 days after the last dose (Up to 26 weeks) Safety population: all enrolled participants who met entry criteria regarding safety data
Gastrointestinal disorders DYSPEPSIA	0.12% 1/862 • Number of events 1 • From start of treatment through 14 days after the last dose (Up to 26 weeks) Safety population: all enrolled participants who met entry criteria regarding safety data
Investigations BLOOD GLUCOSE INCREASED	0.35% 3/862 • Number of events 3 • From start of treatment through 14 days after the last dose (Up to 26 weeks) Safety population: all enrolled participants who met entry criteria regarding safety data
Musculoskeletal and connective tissue disorders UPPER EXTREMITY MASS	0.12% 1/862 • Number of events 1 • From start of treatment through 14 days after the last dose (Up to 26 weeks) Safety population: all enrolled participants who met entry criteria regarding safety data
Psychiatric disorders COMMUNICATION DISORDER	0.12% 1/862 • Number of events 1 • From start of treatment through 14 days after the last dose (Up to 26 weeks) Safety population: all enrolled participants who met entry criteria regarding safety data
Psychiatric disorders INSOMNIA	0.12% 1/862 • Number of events 1 • From start of treatment through 14 days after the last dose (Up to 26 weeks) Safety population: all enrolled participants who met entry criteria regarding safety data

Other adverse events

Measure	ALL PARTICIPANTS n=862 participants at risk
Skin and subcutaneous tissue disorders PRURITUS	7.5% 65/862 • Number of events 65 • From start of treatment through 14 days after the last dose (Up to 26 weeks) Safety population: all enrolled participants who met entry criteria regarding safety data

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication must be approved by the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER