A Study to Evaluate the Lipid Regulating Effects of TRIA-662 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hyperlipidemia	Drug: Low Dose TRIA-662 Drug: High Dose TRIA-662 Drug: Placebo for TRIA-662	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Cortria Corporation:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]


Enrollment:	211
Study Start Date:	September 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Low Dose TRIA-662	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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758303

Sponsors and Collaborators

Cortria Corporation

Investigators


Principal Investigator:	Jean C Tardif, M.D.	Montreal Heart Center

More Information

Additional Information:

Cortria Corporation This link exits the ClinicalTrials.gov site


Responsible Party:	Cortria Corporation
ClinicalTrials.gov Identifier:	NCT00758303 History of Changes
Other Study ID Numbers:	Cortria-001
Study First Received:	September 23, 2008
Last Updated:	August 29, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cortria Corporation:


Triglycerides Cholesterol

Additional relevant MeSH terms:


Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on September 28, 2016