Trial Outcomes & Findings for Study of Trilipix Effects on Lipids and Arteries (NCT NCT01025492)

NCT ID: NCT01025492

Last Updated: 2016-09-01

Results Overview

Comparison of apolipoprotein A-I concentrations after 12 weeks of treatment with either Trilipix or placebo

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 24 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2016-09-01

Participant Flow

The clinical trial collaborator/corporate sponsor prematurely terminated the study and did not provide unblinding information to the investigator or study team, therefore it is not known to which arm/group each of the participants enrolled.

Participant milestones

Measure	Trilipix or Placebo Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Trilipix Effects on Lipids and Arteries

Baseline characteristics by cohort

Measure	Trilipix or Placebo n=24 Participants Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
Age, Continuous	59.5 years STANDARD_DEVIATION 10.3 • n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	16 Participants n=93 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: The clinical trial collaborator/corporate sponsor prematurely terminated the study and did not provide unblinding information to the investigator or study team, therefore it is not known to which arm/group each of the participants enrolled. Additionally, the study outcome measure/endpoint (Apolipoprotein A-I serum concentration) was not analyzed.

Comparison of apolipoprotein A-I concentrations after 12 weeks of treatment with either Trilipix or placebo

Outcome measures

Outcome data not reported

Adverse Events

Trilipix or Placebo

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

Scott Low

University of Utah

Phone: 801-585-1380

Email: scott.low@hsc.utah.edu

Results disclosure agreements

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