Study of Oral MD-0727 Administered to Patients With Primary Hypercholesterolemia

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404001
• Other study ID #: MCP-104-201
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2006
• Last updated: September 28, 2007
• Start date: November 2006
• Est. completion date: July 2007

Study information

• Verified date: September 2007
• Source: Ironwood Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• MD-0727

Locations

Country	Name	City	State
United States	Microbia Investigational Site	Birmingham	Alabama
United States	Microbia Investigational Site	Bristol	Tennessee
United States	Microbia Investigational Site	Charleston	South Carolina
United States	Microbia Investigational Site	Chicago	Illinois
United States	Microbia Investigational Site	Cincinnati	Ohio
United States	Microbia Investigational Site	Edina	Minnesota
United States	Microbia Investigational Site	Indianapolis	Indiana
United States	Microbia Investigational Site	Kansas City	Missouri
United States	Microbia Investigational Site	Lakewood	Washington
United States	Microbia Investigational Site	Los Angeles	California
United States	Microbia Investigational Site	Louisville	Kentucky
United States	Microbia Investigational Site	Marion	Ohio
United States	Microbia Investigational Site	New Port Richey	Florida
United States	Microbia Investigational Site	Olympia	Washington
United States	Microbia Investigational Site	Overland	Kansas
United States	Microbia Investigational Site	Richmond	Virginia
United States	Microbia Investigational Site	San Antonio	Texas
United States	Microbia Investigational Site	Statesville	North Carolina
United States	Microbia Investigational Site	Walnut Creek	California
United States	Microbia Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ironwood Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low density lipoprotein cholesterol (LDL-C)
Secondary	Total cholesterol