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Assess the Safety and Efficacy of NKPL66 (CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia

NCT01516151 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2014-01-08

No results posted yet for this study

Summary

To evaluate the efficacy of 0.5, 1.0, 2.0 and 4.0 g/ day of CaPre™ in reducing fasting plasma serum triglycerides over a four week period in patients with mild-to-high hypertriglyceridemia as compared to the standard of care alone.

Conditions

  • Hypertriglyceridemia

Interventions

DIETARY_SUPPLEMENT

CaPre™

1 capsule of 0.5g total CaPre™ for 4 weeks followed by one 1.0g capsule per day for an additional 4 weeks

DIETARY_SUPPLEMENT

CaPre™

1 capsule of 1.0g total CaPre™ for 4 weeks followed by two 1.0g capsules per day for an additional 4 weeks

DIETARY_SUPPLEMENT

CaPre™

2 capsules of 1.0g total CaPre™ for 4 weeks followed by 4 capsules of 1.0g total per day for an additional 4 weeks.

DRUG

Lipid Lowering Medication

Patient will be treated as per the Standard of care.

DIETARY_SUPPLEMENT

CaPre™

4 capsules of 1 g total per day for 8 weeks.

Sponsors & Collaborators

  • JSS Medical Research Inc.

    collaborator INDUSTRY

  • Grace Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Dufour, M.D. · Institut de Recherches Cliniques de Montreal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-05-31
Completion
2013-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01516151 on ClinicalTrials.gov