Clinical trial NCT00404001: Study of Oral MD-0727 Administered to Patients With Primary Hypercholesterolemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: Microbia
MD-0727
Primary Hypercholesterolemia
Hypercholesterolemia
Hyperlipidemia
Dyslipidemia
Cholesterol
LDL
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Low density lipoprotein cholesterol (LDL-C)
Secondary outcomes:
measure: Total cholesterol
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Microbia Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: Microbia Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Microbia Investigational Site
state: California
city: New Port Richey
country: United States
facility: Microbia Investigational Site
state: Florida
city: Chicago
country: United States
facility: Microbia Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Microbia Investigational Site
state: Indiana
city: Overland
country: United States
facility: Microbia Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Microbia Investigational Site
state: Kentucky
city: Edina
country: United States
facility: Microbia Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: Microbia Investigational Site
state: Missouri
city: Statesville
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Microbia Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Microbia Investigational Site
state: Ohio
city: Marion
country: United States
facility: Microbia Investigational Site
state: Ohio
city: Charleston
country: United States
facility: Microbia Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: Microbia Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: Microbia Investigational Site
state: Texas
city: Richmond
country: United States
facility: Microbia Investigational Site
state: Virginia
city: Lakewood
country: United States
facility: Microbia Investigational Site
state: Washington
city: Olympia
country: United States
facility: Microbia Investigational Site
state: Washington
Study officials:
affiliation: Microbia, Inc.
name: Microbia Medical Affairs
role: STUDY_DIRECTOR
References: