HypertriglyceridemiaPhase 2NCT02008084
A Pilot Study to Evaluate the Lipid Effects of TRIA-662
A Phase 2 study testing TRIA-662 in people with Hypertriglyceridemia and Mixed Hyperlipidemia, run by Cortria Corporation at 17 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertriglyceridemia, Mixed Hyperlipidemia
- What is being tested?
- TRIA-662
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 17 sitesCanada
- Study dates
- Dec 2013to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 45Show fewer
- 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)
- Fibrates/fibric acid derivatives like fenofibrate, gemfibrozil, clofibrate
- Bile acid sequestrants like cholestyramine, colesevelam, colestipol
- HMG-CoA reductase inhibitors (statins) including atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, simvastatin, rosuvastatin
- Ezetimibe
- Omega-3 fatty acids
- Supplements containing flaxseed, tryptophan, fish oil, or algal oil.
- Sterol/stanol products
- Red yeast rice supplements or soy isoflavone supplements.
- Dietary fiber supplements including > 2 teaspoonfuls of Metamucil® or psyllium containing supplements per day.
- Other natural health products or prescription agents judged by the investigator to have the potential to alter serum lipid levels in an individual subject.
- history of angina or myocardial infarction
- hyperuricemia or with a history of gouty arthritis
- known nephritic syndrome or >3 g protein/day in urine at Visit 1
- known familial lipoprotein lipase deficiency, apo CII deficiency, or familial dysbetalipoproteinemia.
- requirement for peritoneal dialysis or hemodialysis for renal insufficiency.
- history of malignancy, except patients who have been disease-free for > 5 yrs, or resected basal or squamous cell skin carcinoma or cervical carcinoma in situ.
- history of bariatric surgery.
- history of pancreatitis, except secondary to cholelithiasis.
- anticipation of major surgery during the study.
- treatment with weight loss drugs or programs during the trial.
- treatment with HIV-protease inhibitors, cyclophosphamide or isotretinoin.
- treatment with tamoxifen, estrogens, or progestins that have not been stable for > 4 week prior to screening at Visit 1
- routine or anticipated use of all systemic corticosteroids at Visit 1. Local, topical, inhaled, or nasal corticosteroids are permitted
- blood donation of > pint (0.5 L) within 30 days prior to screening, or plasma donation within 7 days prior to screening at Visit 1
- consumption of > 14 alcoholic drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor) at Visit 1.
- history of drug abuse at Visit 1
- participation in another clinical trial within 30 days of signing the information and consent form.
- non-compliant to single blind investigational product (< 80% investigational product) or diet as per local judgment between Visit 1 and 4.
- Any condition or therapy that the investigator believes might pose a risk or make participation in the study not in the patient's best interest.
- Poor mental function or any reason to expect difficulty complying with the requirements of the study
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Canada17 sites
Crowfoot Village Family Practice
Calgary, Alberta, T3G0b4
Scisco Clinical Research
Cornwall, Ontario, K6H 4M4
Rhodin Recherche
Drummondville, Quebec, J2B 7T1
Dr. Senaratne Professional Corporation
Edmonton, Alberta, T6K 4C1
Sameh Fikry Medicine Professional Corp
Kitchener, Ontario, N2G 1H6
Aging, Rehabilitation & Geriatric Care, Lawson Health Research Institute-St Joseph's Health Care, Parkwood
London, Ontario, N6C 5J1
Recherche Invascor, Inc.
Longueuil, Quebec, J4N 1C2
GA Research Associates, Ltd
Moncton, New Brunswick, E1G 1A7
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Commonwealth Medical Clinic
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Clinique des Maladies Lipidiques de Quebec, Inc.
Québec, Quebec, G1V 4M6
The Bailey Clinic
Red Deer, Alberta, T4N 6V7
Diex Recherche Sherbrooke
Sherbrooke, Quebec, J1H 1Z1
Prime Health Clinical Research
Toronto, Ontario, M4S 1Y2
Manna Research Inc.
Toronto, Ontario, M9W 4L6
Centre de santé et de services sociaux de Trois-Rivières
Trois-Rivières, Quebec, G8Z 3R9
Manna Research Vancouver
Vancouver, British Columbia, V6J 1S3
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Forced Dose-escalation, Multi-center Pilot Study to Evaluate the Lipid Regulating Effects of TRIA-662 (1-methylnicotinamide Chloride)
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.
Read the detailed description
The primary objective of this pilot study is to assess the feasibility of a large,full-scale study that would evaluate the regulating 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. Upon completion of the 6 to 8 -week dietary-controlled baseline period, subjects meeting all inclusion and no exclusion criteria will be randomized to the double-blind treatment period. In the double-blind treatment period patients will be randomized such that at least 48 subjects will be randomized to TRIA-662 and at least 16 patients will be randomized to placebo (3:1 ratio). The forced-dose titration will be achieved as follows: Weeks 1 - 2: Two 500 mg tablets three times daily with meals (total daily dose 3000 mg); Weeks 3 - 14: Two 1000 mg tablets three times daily with meals (total daily dose 6000 mg).
Investigational product will be administered three times daily with meals (i.e., breakfast, lunch, and dinner). Down titration to 3000 mg daily (two 500 mg tablets, three times daily) is allowed in the event that a patient cannot tolerate the 6000 mg daily treatment for the stipulated period. Under this scenario, the down-titrated patient will remain on the tolerated dose for the remainder of the study. Lipid and ancillary exploratory parameters will be evaluated during the baseline period, upon randomization and throughout the active treatment period. Throughout the study, patients must adhere to a heart-healthy diet, abstain from/minimize ethyl alcohol intake and control any other variables that may alter serum lipid levels (e.g., exercise, weight loss programs, drugs including over the counter agents preparations that may alter serum lipid levels. Safety and tolerability will be assessed throughout the trial through the evaluation of physical exams, electrocardiograms (ECGs), routine hematology and blood chemistry testing, vital signs and adverse events.
- Conditions
- Hypertriglyceridemia, Mixed Hyperlipidemia
- Being tested
- TRIA-662, Placebo
- Keywords
- hypertriglyceridemia, mixed hyperlipidemia
- Medical subject headings
- Hypertriglyceridemia, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIA-662Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TRIA-662 single-blind baseline | Sham comparator | Baseline, 6 to 8-week, dietary lead-in period Receives: Drug: TRIA-662; Drug: Placebo |
| TRIA-662 | Experimental | Following successful completion of the Baseline randomized to active drug Receives: Drug: TRIA-662 |
| Placebo | Placebo comparator | Following successful completion of the Baseline randomized to placebo drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
The number of patients randomized per site per month during the study
Measured: 12 months
Compliance to investigational product
The proportion of randomized patients receiving the investigational product as per protocol.
Measured: 14 weeks
Completion rate
The proportion of randomized patients completing the 14-week follow-up.
Measured: 12 months
Secondary outcomes (14)
Effect on serum high-density lipoprotein cholesterol (HDL-C)
The difference between groups in change from baseline to end of study in serum HDL-C.
Measured: 14 weeks
Variability of serum triglycerides
The standard deviation of the change from baseline to end of study in serum triglycerides.
Measured: 14 weeks
Effect on fasting glucose
The difference between groups in change from baseline to end of study in fasting glucose.
Measured: 14 weeks
Effect on C-reactive protein
The difference between groups in change from baseline to end of study in C-reactive protein.
Measured: 14 weeks
Effect on interleukin-6 (IL-6)
The difference between groups in change from baseline to end of study in IL-6.
Measured: 14 weeks
Effect on total cholesterol (TC)
The difference between groups in change from baseline to end of study in TC
Measured: 14 weeks
Effect on low-density lipoprotein cholesterol (LDL-C)
The difference between groups in change from baseline to end of study in LDL-C
Measured: 14 weeks
Effect on very low-density lipoprotein cholesterol (VLDL-C)
The difference between groups in change from baseline to end of study in (VLDL-C),
Measured: 14 weeks
Effect on total apolipoprotein B (apoB)
The difference between groups in change from baseline to end of study in apoB
Measured: 14 weeks
Effect on total apolipoprotein A1 (apoA1)
The difference between groups in change from baseline to end of study in apoA1
Measured: 14 weeks
Effect on lipoprotein (a) [Lp(a)]
The difference between groups in change from baseline to end of study in Lp(a)
Measured: 14 weeks
Effect on non-high density lipoprotein cholesterol (non-HDL-C)
The difference between groups in change from baseline to end of study in non-HDL-C
Measured: 14 weeks
Effect on TG/HDL-C ratio
The difference between groups in change from baseline to end of study in TG/HDL-C ratio
Measured: 14 weeks
Effect on tumor necrosis factor - alpha (TNF-α)
The difference between groups in change from baseline to end of study in TNF-α
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cortria Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Montreal Heart Institute
- Responsible party
- Sponsor
- Investigators
- Jean-Claude Tardif, MD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008084
- Sponsor's protocol ID
- PNAI-MNA-03
- Status last verified
- Jan 2016
- First submitted
- 6 Dec 2013
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Forced Dose-escalation, Multi-center Pilot Study to Evaluate the Lipid Regulating Effects of TRIA-662 (1-methylnicotinamide Chloride)
- ClinicalTrials.gov ID
- NCT02008084
- Acronym / sponsor ID
- PNAI-MNA-03
- Conditions
- Hypertriglyceridemia, Mixed Hyperlipidemia
- Keywords
- hypertriglyceridemia, mixed hyperlipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Cortria CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Montreal Heart Institute
- Study start
- Dec 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this pilot study is to assess the feasibility of a large,full-scale study that would evaluate the regulating 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. Upon completion of the 6 to 8 -week dietary-controlled baseline period, subjects meeting all inclusion and no exclusion criteria will be randomized to the double-blind treatment period. In the double-blind treatment period patients will be randomized such that at least 48 subjects will be randomized to TRIA-662 and at least 16 patients will be randomized to placebo (3:1 ratio). The forced-dose titration will be achieved as follows: Weeks 1 - 2: Two 500 mg tablets three times daily with meals (total daily dose 3000 mg); Weeks 3 - 14: Two 1000 mg tablets three times daily with meals (total daily dose 6000 mg).
Investigational product will be administered three times daily with meals (i.e., breakfast, lunch, and dinner). Down titration to 3000 mg daily (two 500 mg tablets, three times daily) is allowed in the event that a patient cannot tolerate the 6000 mg daily treatment for the stipulated period. Under this scenario, the down-titrated patient will remain on the tolerated dose for the remainder of the study. Lipid and ancillary exploratory parameters will be evaluated during the baseline period, upon randomization and throughout the active treatment period. Throughout the study, patients must adhere to a heart-healthy diet, abstain from/minimize ethyl alcohol intake and control any other variables that may alter serum lipid levels (e.g., exercise, weight loss programs, drugs including over the counter agents preparations that may alter serum lipid levels. Safety and tolerability will be assessed throughout the trial through the evaluation of physical exams, electrocardiograms (ECGs), routine hematology and blood chemistry testing, vital signs and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRIA-662 single-blind baseline | Sham comparator | Drug: TRIA-662, Drug: PlaceboBaseline, 6 to 8-week, dietary lead-in period |
| TRIA-662 | Experimental | Drug: TRIA-662Following successful completion of the Baseline randomized to active drug |
| Placebo | Placebo comparator | Drug: PlaceboFollowing successful completion of the Baseline randomized to placebo drug |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women of childbearing potential must have a negative serum pregnancy test at screening and Visit 4
- 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.
Key exclusion criteria (45 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIA-662Following 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. | Drug | TRIA-662, TRIA-662 single-blind baseline |
| PlaceboFollowing 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. | Drug | Placebo, TRIA-662 single-blind baseline |
Primary outcome
Recruitment Rate
Time frame: 12 months
The number of patients randomized per site per month during the study
Compliance to investigational product
Time frame: 14 weeks
The proportion of randomized patients receiving the investigational product as per protocol.
Completion rate
Time frame: 12 months
The proportion of randomized patients completing the 14-week follow-up.
14 secondary outcomes
Effect on serum high-density lipoprotein cholesterol (HDL-C)
Time frame: 14 weeks
Variability of serum triglycerides
Time frame: 14 weeks
Effect on fasting glucose
Time frame: 14 weeks
Effect on C-reactive protein
Time frame: 14 weeks
Effect on interleukin-6 (IL-6)
Time frame: 14 weeks
Effect on total cholesterol (TC)
Time frame: 14 weeks
Effect on low-density lipoprotein cholesterol (LDL-C)
Time frame: 14 weeks
Effect on very low-density lipoprotein cholesterol (VLDL-C)
Time frame: 14 weeks
Effect on total apolipoprotein B (apoB)
Time frame: 14 weeks
Effect on total apolipoprotein A1 (apoA1)
Time frame: 14 weeks
Effect on lipoprotein (a) [Lp(a)]
Time frame: 14 weeks
Effect on non-high density lipoprotein cholesterol (non-HDL-C)
Time frame: 14 weeks
Effect on TG/HDL-C ratio
Time frame: 14 weeks
Effect on tumor necrosis factor - alpha (TNF-α)
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Claude Tardif, MD principal investigator
Montreal Heart Institute
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRIA-662 in people with Hypertriglyceridemia and Mixed Hyperlipidemia, run by Cortria Corporation at 17 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.