Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy

This study has been terminated.

Sponsor:

Information provided by:

Medical Research Laboratories International

ClinicalTrials.gov Identifier:

NCT00080132

First received: March 23, 2004

Last updated: June 23, 2005

Last verified: April 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	March 23, 2004
Last Updated Date	June 23, 2005
Start Date ^ICMJE	October 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00080132 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
Official Title ^ICMJE	An Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
Brief Summary	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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hypertriglyceridemia
Intervention ^ICMJE	Drug: implitapide
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	50
Completion Date	April 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	8 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Netherlands, Norway

Administrative Information
NCT Number ^ICMJE	NCT00080132
Other Study ID Numbers ^ICMJE	MRL 2002-003
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Medical Research Laboratories International
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Medical Research Laboratories International
Verification Date	April 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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