HyperlipidemiaPhase 2/3NCT00758303
A Study to Evaluate the Lipid Regulating Effects of TRIA-662
A Phase 2/3 study testing Low Dose TRIA-662 and High Dose TRIA-662 in people with Hyperlipidemia, run by Cortria Corporation.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Low Dose TRIA-662 and High Dose TRIA-662
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Dec 2008
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 22Show fewer
- 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
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of TRIA-662
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.
Read the 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.
- Conditions
- Hyperlipidemia
- Being tested
- Low Dose TRIA-662, High Dose TRIA-662, Placebo for TRIA-662
- Keywords
- Triglycerides, Cholesterol
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose TRIA-662Drug
Also called 1-MNA
One Capsule 3 times a day
High Dose TRIA-662Drug
Also called 1-MNA
3 Capsules 3 times daily
Placebo for TRIA-662Drug
Also called Placebo
Matching Placebo for TRIA-662 taken 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Low Dose TRIA-662 Receives: Drug: Low Dose TRIA-662 |
| 2 | Active comparator | High Dose TRIA-662 Receives: Drug: High Dose TRIA-662 |
| 3 | Placebo comparator | Matching Placebo for TRIA-662 Receives: Drug: Placebo for TRIA-662 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy parameter is the percent change in total serum Triglycerides from baseline to end of study
Measured: Baseline to end of 12 weeks of active treatment
Secondary outcomes (1)
The secondary efficacy parameters include the percent change in total cholesterol (TC), its major lipoprotein sub-fractions and the effects on inflammatory markers
Measured: From baseline to the end of 12 weeks of active treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cortria Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean C Tardif, M.D., Principal investigator, Montreal Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758303
- Sponsor's protocol ID
- Cortria-001
- Status last verified
- Aug 2013
- First submitted
- 23 Sep 2008
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of TRIA-662
- ClinicalTrials.gov ID
- NCT00758303
- Acronym / sponsor ID
- Cortria-001
- Conditions
- Hyperlipidemia
- Keywords
- Triglycerides, Cholesterol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Cortria CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Sep 2008 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Low Dose TRIA-662Low Dose TRIA-662 |
| 2 | Active comparator | Drug: High Dose TRIA-662High Dose TRIA-662 |
| 3 | Placebo comparator | Drug: Placebo for TRIA-662Matching Placebo for TRIA-662 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
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 |
|---|---|---|
| Low Dose TRIA-662Also: 1-MNAOne Capsule 3 times a day | Drug | 1 |
| High Dose TRIA-662Also: 1-MNA3 Capsules 3 times daily | Drug | 2 |
| Placebo for TRIA-662Also: PlaceboMatching Placebo for TRIA-662 taken 3 times a day | Drug | 3 |
Primary outcome
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
1 secondary outcome
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
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 13 Sep 2013.
- Cortria CorporationLink provided by the sponsor.
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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 C Tardif, M.D. principal investigator
Montreal Heart Center
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low Dose TRIA-662 and High Dose TRIA-662 in people with Hyperlipidemia, run by Cortria Corporation.
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 3 inclusion and 22 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 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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). 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 13 Sep 2013.