- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00758303
A Study to Evaluate the Lipid Regulating Effects of TRIA-662
August 29, 2013 updated by: Cortria Corporation
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of TRIA-662
The purpose of this study is to determine the effectiveness and safety of TRIA-662 (also known as 1-MNA) in treating elevated triglyceride levels in patients not receiving lipid lowering treatment.
This study will determine the effects of TRIA-662 on commonly measured blood fats that are known to be important in the prevention of vascular disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, double-blind, placebo-controlled, dose-ranging, multi-center study.
Following a 6-8 week placebo and dietary-controlled baseline period, approximately 195 men and women with either hypertriglyceridemia or mixed hyperlipidemia with serum triglycerides (TG) > 200 mg/dl (2.26 mmol/l) will be randomized to receive either placebo, 30 mg TRIA-662 or 90 mg TRIA-662 three times daily for twelve weeks.
Lipid and ancillary exploratory parameters will be evaluated at screening, during the baseline period, upon randomisation and throughout the 12-week active treatment period.
Study Type
Interventional
Enrollment (Actual)
211
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients at least 18 years of age at the time of informed consent (women of childbearing potential must be practicing adequate contraception)
- Patients with mean serum TG > 200 mg/dl (2.26 mmol/l) and < 700 mg/dl (7.91 mmol/l) as measured at 2 sequential visits during the dietary controlled baseline period (Visits 2 and 3 or Visits 3 and 3a) and having lower level within 25% of upper level (higher value minus lower value)/higher value < 0.25)
- Patients willing and able to sign an informed consent form and follow the protocol
Exclusion Criteria:
- Patients who are pregnant or nursing
- Patients with evidence of hepatic dysfunction [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal (ULN), bilirubin greater than 1.5 times ULN, or cirrhosis] or renal dysfunction (serum creatinine greater than 140 μmol/l, or nephrotic syndrome) as measured during the baseline phase
- Patients with uncontrolled diabetes mellitus (fasting glucose level above 11 mmol/l or HbA1C above 10%) as measured during the baseline phase
- Patients with hypothyroidism that is not treated or not stable for at least 6 months prior to study entry
- Patients with uncontrolled hypertension (systolic blood pressure above 160 mm Hg and/or diastolic blood pressure above 110 mm Hg)
- Patients with systolic blood pressure above 140 mm Hg AND three or more of the following cardiovascular risk factors:
- Current cigarette smoker
- HDL-C < 40 mg/dL (1.04 mmol/L)
- Coronary heart disease in male first degree relative < 55 years of age
- Coronary heart disease in female first degree relative < 65 years of age
- Male age 45 years or older
- Female age 55 years or older
- Patients with known hyperuricemia or with a history of gout
- Patients with an active peptic ulcer
- Patients with known coronary artery disease, cerebrovascular disease or peripheral arterial disease that has previously required percutaneous coronary intervention or surgical intervention
- Patients with known intolerance or allergy to niacin
- Patients consuming more than 10 alcoholic drinks per week
- Patients with a history of drug abuse
- Patients receiving any lipid modifying agent within 4 weeks of entry into the baseline period
- Patients participating in another clinical trial within 30 days of entry into the baseline period
- Patients considered to be non-compliant to study medication (< 80% study medication) or diet during the placebo-baseline phase
- Patients for whom the investigator determines that the study would not be appropriate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Low Dose TRIA-662
|
One Capsule 3 times a day
Other Names:
|
Active Comparator: 2
High Dose TRIA-662
|
3 Capsules 3 times daily
Other Names:
|
Placebo Comparator: 3
Matching Placebo for TRIA-662
|
Matching Placebo for TRIA-662 taken 3 times a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary efficacy parameter is the percent change in total serum Triglycerides from baseline to end of study
Time Frame: Baseline to end of 12 weeks of active treatment
|
Baseline to end of 12 weeks of active treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary efficacy parameters include the percent change in total cholesterol (TC), its major lipoprotein sub-fractions and the effects on inflammatory markers
Time Frame: From baseline to the end of 12 weeks of active treatment
|
From baseline to the end of 12 weeks of active treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean C Tardif, M.D., Montreal Heart Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 23, 2008
First Submitted That Met QC Criteria
September 23, 2008
First Posted (Estimate)
September 25, 2008
Study Record Updates
Last Update Posted (Estimate)
September 13, 2013
Last Update Submitted That Met QC Criteria
August 29, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cortria-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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