Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
NCT ID: NCT00080132
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
50 participants
INTERVENTIONAL
2004-10-31
2005-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
implitapide
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
8 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical Research Laboratories International
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States
The Methodist Hospital
Houston, Texas, United States
Academic Medical Center Amsterdam
Amsterdam, , Netherlands
Andromed Noord
Groningen, , Netherlands
Andromed Leiden
Leiden, , Netherlands
Andromed Rotterdam
Rotterdam, , Netherlands
Andromed Oost
Velp, , Netherlands
Andromed Zoetermeer
Zoetermeer, , Netherlands
Lipidklinikken - Rikshospitalet
Oslo, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MRL 2002-003
Identifier Type: -
Identifier Source: org_study_id