Trial Outcomes & Findings for Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia (NCT NCT01239992)

NCT ID: NCT01239992

Last Updated: 2014-04-10

Results Overview

Percent change of incremental AUC at 12 weeks compared to baseline.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: baseline and 12 weeks after treatment
• Results posted on: 2014-04-10

Participant Flow

Participant milestones

Measure	Niacin/ Laropiprant Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Niacin/ Laropiprant Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Effect of Niacin/Laropiprant on Postprandial Lipoprotein Metabolism in Patients With Dyslipoproteinemia

Baseline characteristics by cohort

Measure	Niacin/ Laropiprant n=12 Participants Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Age, Continuous	64 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Germany	12 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks after treatment

Percent change of incremental AUC at 12 weeks compared to baseline.

Outcome measures

Measure	Niacin/ Laropiprant n=10 Participants Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Incremental Area Under the Plasma Triglyceride Curve Over 8 Hours Following a Standardized Oral Fat Tolerance Test	-28 percentage change Standard Deviation 5

SECONDARY outcome

Timeframe: baseline and 12 weeks after treatment

Percent change of HDL-cholesterol at 12 weeks compared to baseline.

Outcome measures

Measure	Niacin/ Laropiprant n=10 Participants Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
HDL Cholesterol	17 percentage change Standard Deviation 6

SECONDARY outcome

Timeframe: baseline and 12 weeks after treatment

Percent change of fasting triglycerides at 12 weeks compared to baseline

Outcome measures

Measure	Niacin/ Laropiprant n=10 Participants Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
Fasting Triglycerides	-26 percentage change Standard Deviation 15

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 12 weeks after treatment

Percent change of LDL-cholesterol at 12 weeks compared to baseline

Outcome measures

Measure	Niacin/ Laropiprant n=10 Participants Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
LDL-cholesterol	-20 percentage change Standard Deviation 8

Adverse Events

Niacin/ Laropiprant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Klaus G. Parhofer

University Munich

Phone: +49-89-7095-3010

Email: klaus.parhofer@med.uni-muenchen.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place