Efficacy of LCQ908 on Cardiovascular Risk

NCT ID: NCT01474434

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-06-30

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.

Conditions

Coronary Artery Disease; Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pradigastat (LCQ908) followed by placebo

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

Group Type: EXPERIMENTAL

pradigastat (LCQ908)

Intervention Type: DRUG

pradigastat tablets were supplied to the investigators at dose strengths of 10 mg and 20 mg as individual patient packs.

Placebo

Intervention Type: DRUG

matching placebo tablets

Placebo followed by pradigastat (LCQ908)

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

Group Type: EXPERIMENTAL

pradigastat (LCQ908)

Intervention Type: DRUG

pradigastat tablets were supplied to the investigators at dose strengths of 10 mg and 20 mg as individual patient packs.

Placebo

Intervention Type: DRUG

matching placebo tablets

Interventions

pradigastat (LCQ908)

pradigastat tablets were supplied to the investigators at dose strengths of 10 mg and 20 mg as individual patient packs.

Intervention Type: DRUG

Placebo

matching placebo tablets

Intervention Type: DRUG

Other Intervention Names

Pradigastat

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Pasadena, California, United States

Countries

United States

Other Identifiers

CLCQ908A2213

Identifier Type: -

Identifier Source: org_study_id