|
Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy Clinical research trials and Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy. Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy  Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
For Condition: Familial Hypercholesterolemia
Status: Recruiting
Sponsor(s): Medical Research Laboratories International ,
Synopsis: The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH).
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 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 18 and 70 years old with a diagnosis of HeFH; - be stable on and maintain concomitant therapy with hypolipidemic drugs or treatments; - have an appropriate calculated, fasting LDL-C levels and an appropriate triglyceride (TG) level; - be male or nonpregnant, nonlactating female; - give informed consent; and - meet body weight requirements. Exclusion Criteria: In order to participate in this study, patients must not meet any of the following exclusion criteria: - recent myocardial infarction, percutaneous transluminal coronary intervention, coronary artery bypass graft surgery, or cerebrovascular accident; - uncontrolled hypothyroidism or other uncontrolled endocrine disease; - known, clinically significant eye abnormalities (e.g., cataracts); - appropriate serum creatinine phosphokinase levels; - history of liver disease or liver enzyme levels above appropriate levels; - alkaline phosphatase above appropriate levels; - serum creatinine above appropriate levels; - liver cirrhosis and severe liver steatosis; - clinically significant infection, malignancy, or psychosis; - use of oral anticoagulants or digoxin, unless the dose has been stable for 4 weeks; - participation in any other investigational study, including device or observational studies, within 30 days; - lactating or have a positive serum pregnancy test; - current drug or alcohol abuse; or - unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator
Total Enrollment: 120
Location and Contact Information:
Andromed Oost *Recruiting*
Velp, ,
Netherlands
Recruiting
Andromed Rotterdam *Recruiting*
Rotterdam, ,
Netherlands
Recruiting
Andromed Leiden *Recruiting*
Leiden, ,
Netherlands
Recruiting
Andromed Zoetermeer *Recruiting*
Zoetermeer, ,
Netherlands
Recruiting
Lipidklinikken - Rikshospitalet *Recruiting*
Oslo, ,
Norway
Recruiting
Metabolic and Atherosclerosis Research Center *Recruiting*
Cincinnati, Ohio, 45229
United States
Recruiting
Additional Information:
Study ID Numbers: MRL 2002-002;
Study Start Date: October 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079859
Other Familial Hypercholesterolemia Studies:
1. Phase I Study of Ex Vivo Liver-Directed Gene Therapy for Familial Hypercholesterolemia
2. Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
3. Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
Related Studies:
Other Familial Hypercholesterolemia Clinical Trials
Other Clinical Trials
Other Zoetermeer Clinical Trials
Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
|
|
|
|
|
|
|
|
