Efficacy of LCQ908 on Cardiovascular Risk

Novartis

Status and phase: Terminated; Phase 2

Conditions: Coronary Artery Disease; Hypertriglyceridemia

Treatments: Drug: Placebo; Drug: pradigastat (LCQ908)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01474434

CLCQ908A2213

Details and patient eligibility

About

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

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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41 participants in 2 patient groups

Pradigastat (LCQ908) followed by placebo

Experimental group

Description:

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

Treatment:

Drug: pradigastat (LCQ908)

Drug: Placebo

Placebo followed by pradigastat (LCQ908)

Experimental group

Description:

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

Treatment:

Drug: pradigastat (LCQ908)

Drug: Placebo