NCT01474434

Efficacy of LCQ908 on Cardiovascular Risk

A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of LCQ908 on Cardiovascular Risk

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	pradigastat (LCQ908)	pradigastat tablets were supplied to the investigators at dose strengths of 10 mg and 20 mg as individual patient packs.
DRUG	Placebo	matching placebo tablets

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2011-11-18
• Last updated: 2016-04-14
• Results posted: 2016-04-14

Locations

1 site across 1 country: United States