Study of Oral MD-0727 Administered to Patients With Primary Hypercholesterolemia
NCT ID: NCT00404001
Last Updated: 2007-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2006-11-30
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Interventions
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MD-0727
Eligibility Criteria
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Inclusion Criteria
* Patient must agree to use contraception and/or birth control if sexually active
* Patient may not be on lipid-lowering therapies at least 6 weeks prior to study and must have a fasting LDL-C 130 mg/dl or greater at Screening
* Patient must have an average of two fasting LDL-C measures greater than/equal to 130 mg/dl but less than/equal to 210 mg/dl with a difference in the two measures less than/equal to 15%. Patient may not have a fasting serum triglyceride less than 300 mg/dl during Pre-treatment Period
* Patient's BMI must be greater than/equal to 18.5 but less than 35.0 at Screening
* Patient must complete a physical exam, 12-lead ECG, and other laboratory tests (including pregnancy test) with no clinically-significant findings prior to the first dose of study medication
* Patient agrees to comply with the TLC diet
* Patient completes a 6-week washout of previous lipid-lowering medication including over-the-counter products
Exclusion Criteria
* Patient has a TSH level \>1.5 X the upper limit of normal
* Patient has history of cardiovascular or coronary artery disease, uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, or patient has history of NYHA Class III or IV congestive heart failure
* Patient is diabetic or presents with fasting blood glucose greater than/equal to 126 mg/dl at any time prior to randomization
* Patient has uncontrolled hypertension with a systolic blood pressure greater than/equal to 180 mm Hg or diastolic blood pressure greater than/equal to 110 mmg Hg at two study visits prior to the first dose of study medication
* Patient has a 10-year CHD risk of \> 20%
* Patient has ALT or AST \> 1.5 X the upper limit of normal prior to randomization
* Patient has a history of alcohol or drug abuse within 12 months of Screening
* Patient has used a prohibited medication (per protocol) during the 14-day Pre-treatment Visit
18 Years
ALL
No
Sponsors
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Ironwood Pharmaceuticals, Inc.
INDUSTRY
Principal Investigators
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Microbia Medical Affairs
Role: STUDY_DIRECTOR
Microbia, Inc.
Locations
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Microbia Investigational Site
Birmingham, Alabama, United States
Microbia Investigational Site
Los Angeles, California, United States
Microbia Investigational Site
Walnut Creek, California, United States
Microbia Investigational Site
New Port Richey, Florida, United States
Microbia Investigational Site
Chicago, Illinois, United States
Microbia Investigational Site
Indianapolis, Indiana, United States
Microbia Investigational Site
Overland, Kansas, United States
Microbia Investigational Site
Louisville, Kentucky, United States
Microbia Investigational Site
Edina, Minnesota, United States
Microbia Investigational Site
Kansas City, Missouri, United States
Microbia Investigational Site
Statesville, North Carolina, United States
Microbia Investigational Site
Winston-Salem, North Carolina, United States
Microbia Investigational Site
Cincinnati, Ohio, United States
Microbia Investigational Site
Marion, Ohio, United States
Microbia Investigational Site
Charleston, South Carolina, United States
Microbia Investigational Site
Bristol, Tennessee, United States
Microbia Investigational Site
San Antonio, Texas, United States
Microbia Investigational Site
Richmond, Virginia, United States
Microbia Investigational Site
Lakewood, Washington, United States
Microbia Investigational Site
Olympia, Washington, United States
Countries
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Other Identifiers
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MCP-104-201
Identifier Type: -
Identifier Source: org_study_id