Clinical trial NCT01474434: Efficacy of LCQ908 on Cardiovascular Risk
Official title: A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of LCQ908 on Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Coronary Artery Disease
Hypertriglyceridemia
Keywords: coronary artery disease,
LCQ908,
hyperlipidemia,
hypertriglyceridemia,
pradigastat
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study designed to evaluate the potential for the pradigastat (LCQ908) to impact cardiovascular risk.

Detailed description: This study had 2 parts. Part A was a multicenter, double-blind, randomized, placebo-controlled, non-confirmatory crossover study assessing response to a high-fat meal challenge in the setting of pradigastat versus placebo. Part A had 2 cohorts i.e. Cohort 1 patients with stable coronary artery disease and hypertriglyceridemia and Cohort 2 patients with asymptomatic non-obstructive coronary artery disease or elevated coronary heart disease risk and hypertriglyceridemia.

Part B was a double blinded phase designed to assess response to three months of chronic treatment with pradigastat versus placebo on a normal diet.

The trial was terminated after the interim analysis of Part A, Cohort 1. The interim analysis results indicated that the high-fat meal challenge did not induce any impairment on either myocardial perfusion reserve index (MPRi) or exercise treadmill performance. Part B was never started.

Eligibility criteria: Inclusion Criteria:

* History of coronary artery disease
* Elevated triglycerides
* On medication to help lower cholesterol

Exclusion Criteria:

* Poorly controlled diabetic patients and/or change in diabetic medication within 12 weeks of screening
* History of myocardial infarction (heart attack) within 6 months of screening
* History of a procedure to open a blocked coronary artery within 12 months of enrollment
* History of Coronary Artery Bypass Graft (CABG) surgery
* History of congestive heart failure
* History of significant heart valve disease

Primary outcomes:
measure: Change From Baseline in Myocardial Perfusion Reserve Index (MPRi) Overall Mean (Part A, Cohort 1)
timeFrame: Baseline, and on day 5 of each of the two treatment periods
measure: Change From Baseline in Total Exercise Duration (Part A, Cohort 1)
timeFrame: Baseline and on day 5 of each of the two treatment periods
measure: Time to Onset of Angina (Part A, Cohort 1)
timeFrame: Baseline and on day 5 of each of the two treatment periods
measure: Time to Onset of Exercise-induced Ischemia(Part A, Cohort 1)
timeFrame: Baseline and on day 5 of each of the two treatment periods
measure: Aortic Plaque Inflammation (Part B)
timeFrame: Baseline and on treatment day 85 +/- 3 days
Secondary outcomes:
measure: Number of Participants With Adverse Events (Part A, Cohort 1)
timeFrame: approximately 40 days
measure: Number of Participants With Adverse Events (Part A, Cohort 2)
timeFrame: approximately 40 days
measure: Postprandial Triglycerides (Part A, Cohort 1)
timeFrame: 0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5
measure: Postprandial Triglycerides (Part A, Cohort 2)
timeFrame: 0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5
measure: Pharmacokinetics of Pradigastat (LCQ908): Plasma Concentration (Part A)
timeFrame: Part A: Day 4 and day 5 of each treatment period
measure: Other Related Lipid Parameters (Part A)
timeFrame: Baseline, day 4 and day 5 of each treatment period
measure: Interleukin-6 (IL-6) Level (Part A)
timeFrame: Baseline, day 4 and day 5, of each treatment period
measure: C-reactive Protein (CRP) Level (Part A)
timeFrame: Baseline, day 4 and day 5, of each treatment period
measure: Adiponectin Level ( Part B)
timeFrame: Part B; Baseline, day 15, day 43 and day 85
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Novartis Investigative Site
state: California
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: