Conditions: Coronary Artery Disease Hypertriglyceridemia
Keywords: coronary artery disease, LCQ908, hyperlipidemia, hypertriglyceridemia, pradigastat
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 41
Healthy volunteers: no

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.

Arms:
arm 1: Pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment arm 2: Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by p20 mg (2 x 10-mg tablets) daily for two days

Interventions: intervention 1: pradigastat (LCQ908) intervention 2: Placebo
Intervention descriptions: intervention 1: pradigastat tablets were supplied to the investigators at dose strengths of 10 mg and 20 mg as individual patient packs. intervention 2: matching placebo tablets

Protocol document: