Trial intelligence / Profile preview

TRIA-662 in Hypertriglyceridemia

NCT00758303Phase 3

Key facts

Status
Completed
Start
Sep 2007
Primary completion
Dec 2008
Sponsor
Cortria
Modality
Small Molecules
Conditions
hypertriglyceridemia
01

Overview

Phase 3, randomised, double-blind trial of 1-methylnicotinamide in hypertriglyceridemia (3 arms), sponsored by Cortria. Primary endpoint: Percent change in total serum Triglycerides from baseline to end of study at 12 weeks. Started Sep 2007; status: completed.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • Low Dose TRIA-662

    30 mg TRIA-662 three times daily

  • High Dose TRIA-662

    90 mg TRIA-662 three times daily

  • Placebo

    Matching Placebo for TRIA-662 taken 3 times a day

03

Who it enrols

Adult patients with hypertriglyceridemia or mixed hyperlipidemia (TG > 200 mg/dl and < 700 mg/dl) not receiving lipid lowering treatment.

04

Endpoints

Primary

  • Percent change in total serum Triglycerides from baseline to end of study

Secondary

  • Percent change in total cholesterol (TC)

  • Percent change in major lipoprotein sub-fractions

  • Effects on inflammatory markers

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