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

Hyperlipidemia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of TRIA-662

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758303
• Other study ID #: Cortria-001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 23, 2008
• Last updated: August 29, 2013
• Start date: September 2007
• Est. completion date: December 2008

Study information

• Verified date: August 2013
• Source: Cortria Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Drug:
• Low Dose TRIA-662
One Capsule 3 times a day
• High Dose TRIA-662
3 Capsules 3 times daily
• Placebo for TRIA-662
Matching Placebo for TRIA-662 taken 3 times a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cortria Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy parameter is the percent change in total serum Triglycerides from baseline to end of study		Baseline to end of 12 weeks of active treatment	Yes
Secondary	The secondary efficacy parameters include the percent change in total cholesterol (TC), its major lipoprotein sub-fractions and the effects on inflammatory markers		From baseline to the end of 12 weeks of active treatment	No

External Links

•   Cortria Corporation