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

NCT02008084 | Completed Phase 2

• 1 other identifier: PNAI-MNA-03
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 17

Brief Summary

The purpose of this pilot study is to learn what study factors are important in designing a large, full-scale study of the effects of TRIA-662 on serum triglycerides (TG) and high-density lipoprotein cholesterol (HDL-C) levels. In this study, patients will first enter a Single-blind, dietary-controlled baseline period and receive 1000 mg placebo or active drug three times daily with meals (i.e., breakfast, lunch, and dinner) for 6 - 8 weeks. If the qualify to continue, they will then receive up to 2000 mg of active or placebo drug for an additional 14 weeks. Active drug will be given to 48 patients and placebo drug will be given to 16 patients. However, neither the patients not the clinic staff will know which patients are on active or placebo drug until the end of the study.

Conditions

Hypertriglyceridemia; Mixed Hyperlipidemia

Keywords

hypertriglyceridemia; mixed hyperlipidemia

Outcome Measures

Primary Outcomes (3)

• Recruitment Rate

  The number of patients randomized per site per month during the study

  12 months

• Compliance to investigational product

  The proportion of randomized patients receiving the investigational product as per protocol.

  14 weeks

• Completion rate

  The proportion of randomized patients completing the 14-week follow-up.

  12 months

Secondary Outcomes (14)

• Effect on serum high-density lipoprotein cholesterol (HDL-C)

  14 weeks

• Variability of serum triglycerides

  14 weeks

• Effect on fasting glucose

  14 weeks

• Effect on C-reactive protein

  14 weeks

• Effect on interleukin-6 (IL-6)

  14 weeks

Study Arms (3)

TRIA-662 single-blind baseline

SHAM COMPARATOR

Baseline, 6 to 8-week, dietary lead-in period

Drug: TRIA-662; Drug: Placebo

TRIA-662

EXPERIMENTAL

Following successful completion of the Baseline randomized to active drug

Drug: TRIA-662

Placebo

PLACEBO COMPARATOR

Following successful completion of the Baseline randomized to placebo drug

Drug: Placebo

Interventions

TRIA-662 DRUG

Following Baseline randomized to active TRIA-662 2 x 500 mg tablets, three times daily with meals for 2 weeks and then active TRIA-662 2 x 1000 mg tablets, three times daily with meals for 12 weeks.

TRIA-662; TRIA-662 single-blind baseline

Placebo DRUG

Following Baseline randomized to placebo TRIA-662 2 x 500 mg tablets, three times daily with meals for 2 weeks and then placebo TRIA-662 2 x 1000 mg tablets, three times daily with meals for 12 weeks.

Placebo; TRIA-662 single-blind baseline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women of childbearing potential must have a negative serum pregnancy test at screening and Visit 4
• Women are considered not of childbearing potential if they:
• have had a hysterectomy or tubal ligation prior to Visit 1.
• are postmenopausal (12 months no menses or menopausal follicle stimulating hormone level) Women of childbearing potential must agree to use an effective method of birth control throughout the study. Acceptable means of birth control include: implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, male or female condoms with spermicide, abstinence, or a sterile sexual partner.
• Patients who at Weeks -4 and -2 demonstrate mean LDL-C at the levels at which lipid-modifying drug therapy is not indicated according to investigator judgment under ATP III guidelines.
• Patients who demonstrate mean serum triglycerides = or \>200 mg/dL (2.26 mmol/L) but \< or = 500 mg/dL (5.65 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 to maintain a stable diet and physical activity level throughout the study
• Patients willing and able to sign the information and consent form and follow the protocol including availability for all visits/telephone follow-up for approximately 24 weeks.

You may not qualify if:

• pregnant, planning to become pregnancy during the study, or nursing
• clinically significant electrocardiographic abnormalities at Visit 1 or 4
• body mass index \> 45 kg/m2 at Visit 1
• weight change of \> 5% of initial body weight between Visit 1 and 4
• poorly controlled diabetes defined as a hemoglobin A1c \> 9.5% prior to Visit 4
• evidence of hepatic disease (ALT or AST greater than 2.0 upper limit of normal (ULN), bilirubin \> 1.5 ULN, or cirrhosis) at visit 1
• renal dysfunction defined as glomerular filtration rate (GFR) \< 60 mL/min/1.73 m2 at Visit 1
• hypothyroidism that is not treated or not stable for at least 6 months prior to study entry
• poorly controlled hypertension defined as a mean systolic blood pressure \> 160 mm Hg and/or diastolic blood pressure \> 100 mmHg at Visit 1. In individuals with end-organ damage, mean systolic blood pressure \> 140 mmHg and mean diastolic blood pressure \> 90 mmHg at Visit 1
• severe hypotension defined as systolic blood pressure =\< 90 mm Hg or diastolic blood pressure =\< 60 mm Hg AND symptomatic
• active peptic ulcer
• known intolerance or allergy to niacin (nicotinic acid), niacinamide (nicotinamide), or any of the tablet ingredients: 1-methylnicotinamide chloride, microcrystalline cellulose, povidone, silicified microcrystalline cellulose, crospovidone, anhydrous dibasic calcium phosphate, hydroxypropyl cellulose, magnesium stearate (vegetable origin), polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol, methacrylic acid copolymer, and sodium bicarbonate.
• any known history of coronary artery disease, cerebrovascular disease or peripheral arterial disease
• Use after screening to the conclusion of the study of any of the following lipid modifying medications/supplements:
• Niacin (nicotinic acid) or niacinamide (nicotinamide)

Sponsors & Collaborators

• Cortria Corporation: lead
• Montreal Heart Institute: collaborator

Study Sites (17)

Crowfoot Village Family Practice

Calgary, Alberta, T3G0b4, Canada

Location

Dr. Senaratne Professional Corporation

Edmonton, Alberta, T6K 4C1, Canada

Location

The Bailey Clinic

Red Deer, Alberta, T4N 6V7, Canada

Location

Manna Research Vancouver

Vancouver, British Columbia, V6J 1S3, Canada

Location

GA Research Associates, Ltd

Moncton, New Brunswick, E1G 1A7, Canada

Location

Commonwealth Medical Clinic

Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada

Location

Scisco Clinical Research

Cornwall, Ontario, K6H 4M4, Canada

Location

Sameh Fikry Medicine Professional Corp

Kitchener, Ontario, N2G 1H6, Canada

Location

Aging, Rehabilitation & Geriatric Care, Lawson Health Research Institute-St Joseph's Health Care, Parkwood

London, Ontario, N6C 5J1, Canada

Location

Prime Health Clinical Research

Toronto, Ontario, M4S 1Y2, Canada

Location

Manna Research Inc.

Toronto, Ontario, M9W 4L6, Canada

Location

Rhodin Recherche

Drummondville, Quebec, J2B 7T1, Canada

Location

Recherche Invascor, Inc.

Longueuil, Quebec, J4N 1C2, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Clinique des Maladies Lipidiques de Quebec, Inc.

Québec, Quebec, G1V 4M6, Canada

Location

Diex Recherche Sherbrooke

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Centre de santé et de services sociaux de Trois-Rivières

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

MeSH Terms

Conditions

Hypertriglyceridemia; Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias

Study Officials

• Jean-Claude Tardif, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

CA (17)