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

September 28, 2007 updated by: Ironwood Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Low density lipoprotein cholesterol (LDL-C)

Secondary Outcome Measures

Outcome Measure
Total cholesterol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ironwood Pharmaceuticals, Inc.

Investigators

  • Study Director: Microbia Medical Affairs, Microbia, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

November 22, 2006

First Submitted That Met QC Criteria

November 22, 2006

First Posted (Estimate)

November 27, 2006

Study Record Updates

Last Update Posted (Estimate)

October 1, 2007

Last Update Submitted That Met QC Criteria

September 28, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCP-104-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe