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Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy Clinical research trials and Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy healthcare trials happen in a lot of of localities across the United States of America. 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 / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy. Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy clinical trial. Human subjects often receive the most effective healthcare possible for their Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy  Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) 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 homozygous familial hypercholesterolemia (HoFH).
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, 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 a diagnosis of HoFH; - 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 and height 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; - 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; - history of or 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: 60
Location and Contact Information:
Lipid Research Center, CHUL du CHUQ *Recruiting*
Sainte-Foy, Quebec, G1V 4G2
Canada
Recruiting
Metabolic and Atherosclerosis Research Center *Recruiting*
Cincinnati, Ohio, 45229
United States
Recruiting
Lipid Clinic and Community Genomic Center, Complexe Hospitalier de la Sagamie *Recruiting*
Chicoutimi, Quebec, G7H 5H6
Canada
Recruiting
Lipidklinikken - Rikshospitalet *Recruiting*
Oslo, , N-0027
Norway
Recruiting
Academic Medical Center Amsterdam *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting
Hadassah University Hospital *Recruiting*
Jerusalem, , 91120
Israel
Recruiting
Additional Information:
Study ID Numbers: MRL 2002-001;
Study Start Date: September 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079846
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 Quebec Clinical Trials
Other Chicoutimi Clinical Trials
Implitapide in Patients with Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
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