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Lipase Inhibitor
Efficacy of LCQ908 on Cardiovascular Risk
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and on treatment day 85 +/- 3 days
Summary
This is a study designed to evaluate the potential for the pradigastat (LCQ908) to impact cardiovascular risk.
Eligible Conditions
- High Triglycerides
- Coronary Artery Disease
- Hypertriglyceridemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and on treatment day 85 +/- 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and on treatment day 85 +/- 3 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Aortic Plaque Inflammation (Part B)
Change From Baseline in Myocardial Perfusion Reserve Index (MPRi) Overall Mean (Part A, Cohort 1)
Change From Baseline in Total Exercise Duration (Part A, Cohort 1)
+2 moreSecondary study objectives
Postprandial Triglycerides (Part A, Cohort 1)
Postprandial Triglycerides (Part A, Cohort 2)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pradigastat (LCQ908) followed by placeboExperimental Treatment2 Interventions
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 II: Placebo followed by pradigastat (LCQ908)Experimental Treatment2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,921 Previous Clinical Trials
4,254,271 Total Patients Enrolled