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Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy Clinical research trials and Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy. Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy clinical trial. Test subjects typically obtain the finest healthcare available for their Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy  Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy
Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy
For Condition: Hypertriglyceridemia
Status: Recruiting
Sponsor(s): Medical Research Laboratories International ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 8 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 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 Exclusion Criteria: - 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 - 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
Total Enrollment: 50
Location and Contact Information:
Andromed Leiden *Recruiting*
Leiden, , 2311 GZ
Netherlands
Recruiting
Andromed Noord *Recruiting*
Groningen, , 9711 SG
Netherlands
Recruiting
Lipidklinikken - Rikshospitalet *Recruiting*
Oslo, ,
Norway
Recruiting
Metabolic and Atherosclerosis Research Center *Recruiting*
Cincinnati, Ohio, 45229
United States
Recruiting
The Methodist Hospital *Recruiting*
Houston, Texas, 77030
United States
Recruiting
Andromed Oost *Recruiting*
Velp, , 6883 HM
Netherlands
Recruiting
Andromed Rotterdam *Recruiting*
Rotterdam, , 3021 HC
Netherlands
Recruiting
Andromed Zoetermeer *Recruiting*
Zoetermeer, , 2724 EK
Netherlands
Recruiting
Academic Medical Center Amsterdam *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting
Additional Information:
Study ID Numbers: MRL 2002-003;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080132
Other Hypertriglyceridemia Studies:
1. Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy
2. Genetic Determinants:Low HDL, High Triglycerides, Obesity
3. Re-evaluating Triglycerides in Coronary Heart Disease
4. The Effect of Fish Oil Plus Fenofibrate on Triglyceride Levels in People Taking Highly Active Antiretroviral Therapy (HAART)
5. Niacin for Treatment of Elevated Cholesterol and Triglycerides in HIV-Infected Patients
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Implitapide in Patients with Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-lowering Therapy
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