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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00404001
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : October 1, 2007
Information provided by:
Ironwood Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: MD-0727 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Low density lipoprotein cholesterol (LDL-C)

Secondary Outcome Measures :
  1. Total cholesterol

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00404001

  Show 20 Study Locations
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
Study Director: Microbia Medical Affairs Microbia, Inc. Identifier: NCT00404001     History of Changes
Other Study ID Numbers: MCP-104-201
First Posted: November 27, 2006    Key Record Dates
Last Update Posted: October 1, 2007
Last Verified: September 2007

Keywords provided by Ironwood Pharmaceuticals, Inc.:
Primary Hypercholesterolemia

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases