|
Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy conditions. Clinical Trials Search.org is a website 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 occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 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 permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated 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. Human subjects often get the best healthcare possible for their Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
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 Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
3. Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
Related Studies:
Other Familial Hypercholesterolemia Clinical Trials
Other Clinical Trials
Other Oslo Clinical Trials
Implitapide in Patients with Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
|
|
|
|
|
|
|
|
