HypertriglyceridemiaPhase 2NCT00080132
Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
A Phase 2 study testing implitapide in people with Hypertriglyceridemia, run by Medical Research Laboratories International at 9 sites in 3 countries.
Trial summary
The purpose of this study is to determine if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not sufficient. Read more about this study
- Who is it for?
- Ages 8 to 70 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- implitapide
- How many people
- 50 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Oct 2004to Apr 2005
- 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 8 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- In order to participate in this study, patients must meet all of the following inclusion criteria:
- be between 8 and 70 years old with diagnosis of Fredrickson Type I or V HTG
- be stable on current maximum tolerated triglyceride lowering therapy
- have a fasting TG level of at least 880 mg/dL (10 mmol/L)
- be male or nonpregnant, nonbreastfeeding female. The women in the study must be surgically sterile, postmenopausal or must practice an effective method of birth control
- must be able to give informed consent or if under the age of 18, parents or legal guardians must give their informed consent
- meet body weight requirements
Who cannot join
- Recent heart attack, coronary artery intervention, coronary bypass surgery, or stroke.
- Patients with class 3 or 4 heart failure
- Uncontrolled hypothyroidism or other uncontrolled endocrine disease
- Known, clinically significant eye abnormalities, such as cataracts
- History of hepatic disease or AST or ALT levels greater than 1.5 x ULN at Visit 1
- Alkaline phosphatase greater than 2 times ULN
Show all 15Show fewer
- Serum creatinine greater than 2.0 mg/dL
- Liver cirrhosis and severe liver steatosis
- Clinically significant infection, malignancy, or psychosis
- Use of oral anticoagulants or digoxin unless the dose is stable and is regularly monitored
- Participation in any other investigational study within the last 30 days
- Breastfeeding or pregnant
- Current drug or alcohol abuse
- Serious or unstable medical conditions that would compromise the patient's safety or successful participation in the study
- Unwillingness to comply with study procedures or unwillingness to cooperate fully
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Netherlands6 sites
Academic Medical Center Amsterdam
Amsterdam, 1105 AZ
Andromed Noord
Groningen, 9711 SG
Andromed Leiden
Leiden, 2311 GZ
Andromed Rotterdam
Rotterdam, 3021 HC
Andromed Oost
Velp, 6883 HM
Andromed Zoetermeer
Zoetermeer, 2724 EK
United States2 sites
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, 45229
The Methodist Hospital
Houston, Texas, 77030
About this study
Official title: An Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
The purpose of this study is to determine if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not sufficient.
- Conditions
- Hypertriglyceridemia
- Being tested
- implitapide
- Keywords
- HTG, Hypertriglyceridemia, Fredrickson Type I, Hypertriglyceridemia, Fredrickson Type V
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implitapideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2004 (estimated)
- Study startOct 2004
- Study completionApr 2005
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
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Medical Research Laboratories International
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080132
- Sponsor's protocol ID
- MRL 2002-003
- Status last verified
- Apr 2005
- First submitted
- 23 Mar 2004
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
- ClinicalTrials.gov ID
- NCT00080132
- Acronym / sponsor ID
- MRL 2002-003
- Conditions
- Hypertriglyceridemia
- Keywords
- HTG, Hypertriglyceridemia, Fredrickson Type I, Hypertriglyceridemia, Fredrickson Type V
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants
- Lead sponsor
- Medical Research Laboratories InternationalIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Apr 2005
- First posted
- 25 Mar 2004 (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 if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not sufficient.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- In order to participate in this study, patients must meet all of the following inclusion criteria:
- be between 8 and 70 years old with diagnosis of Fredrickson Type I or V HTG
- be stable on current maximum tolerated triglyceride lowering therapy
- have a fasting TG level of at least 880 mg/dL (10 mmol/L)
- be male or nonpregnant, nonbreastfeeding female. The women in the study must be surgically sterile, postmenopausal or must practice an effective method of birth control
Key exclusion criteria (15 listed)
- Recent heart attack, coronary artery intervention, coronary bypass surgery, or stroke.
- Patients with class 3 or 4 heart failure
- Uncontrolled hypothyroidism or other uncontrolled endocrine disease
- Known, clinically significant eye abnormalities, such as cataracts
- History of hepatic disease or AST or ALT levels greater than 1.5 x ULN at Visit 1
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 |
|---|---|---|
| implitapide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing implitapide in people with Hypertriglyceridemia, run by Medical Research Laboratories International at 9 sites in 3 countries.
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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands, United States, Norway. 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. 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 was stopped early. Results are not available in the source record.
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.
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 24 Jun 2005.