A Study to Evaluate the Lipid Regulating Effects of TRIA-662
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ClinicalTrials.gov Identifier: NCT00758303 |
Recruitment Status :
Completed
First Posted : September 25, 2008
Last Update Posted : September 13, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperlipidemia | Drug: Low Dose TRIA-662 Drug: High Dose TRIA-662 Drug: Placebo for TRIA-662 | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 211 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of TRIA-662 |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Low Dose TRIA-662
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Drug: Low Dose TRIA-662
One Capsule 3 times a day
Other Name: 1-MNA |
Active Comparator: 2
High Dose TRIA-662
|
Drug: High Dose TRIA-662
3 Capsules 3 times daily
Other Name: 1-MNA |
Placebo Comparator: 3
Matching Placebo for TRIA-662
|
Drug: Placebo for TRIA-662
Matching Placebo for TRIA-662 taken 3 times a day
Other Name: Placebo |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758303
Principal Investigator: | Jean C Tardif, M.D. | Montreal Heart Center |
Responsible Party: | Cortria Corporation |
ClinicalTrials.gov Identifier: | NCT00758303 |
Other Study ID Numbers: |
Cortria-001 |
First Posted: | September 25, 2008 Key Record Dates |
Last Update Posted: | September 13, 2013 |
Last Verified: | August 2013 |
Triglycerides Cholesterol |
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |