Status:
COMPLETED
A Study to Evaluate the Lipid Regulating Effects of TRIA-662
Lead Sponsor:
Cortria Corporation
Conditions:
Hyperlipidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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. Th...
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 eith...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00758303
Start Date
September 1 2007
End Date
December 1 2008
Last Update
September 13 2013
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