Study of Oral MD-0727 Administered to Patients With Primary Hypercholesterolemia
A Phase 2, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Range-Finding Study of the Safety and Efficacy of Orally Administered MD-0727 in Patients With Primary Hypercholesterolemia
1 other identifier
interventional
150
1 country
20
Brief Summary
The primary objectives of this study are to evaluate the safety of MD-0727 in patients with primary hypercholesterolemia and to determine the low density lipoprotein cholesterol (LDL-C) lowering effect and dose-response of MD-0727 in patients with primary hypercholesterolemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2006
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 22, 2006
CompletedFirst Posted
Study publicly available on registry
November 27, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedOctober 1, 2007
September 1, 2007
November 22, 2006
September 28, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Low density lipoprotein cholesterol (LDL-C)
Secondary Outcomes (1)
Total cholesterol
Interventions
Eligibility Criteria
You may qualify if:
- Patient is male or non-pregnant, non-breastfeeding female, at least 18 years of age
- 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
You may not qualify if:
- Patient has a medical condition that is prohibited per protocol or a condition that the Investigator believes may limit the patient's ability to participate in the study
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Microbia Medical Affairs
Microbia, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 22, 2006
First Posted
November 27, 2006
Study Start
November 1, 2006
Study Completion
July 1, 2007
Last Updated
October 1, 2007
Record last verified: 2007-09