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

This study has been completed.
Sponsor:
Information provided by:
Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00404001
First received: November 22, 2006
Last updated: September 28, 2007
Last verified: September 2007
  Purpose

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 Intervention Phase
Hypercholesterolemia
Drug: MD-0727
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Ironwood Pharmaceuticals, Inc.:

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

Secondary Outcome Measures:
  • Total cholesterol

Enrollment: 150
Study Start Date: November 2006
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404001

  Show 20 Study Locations
Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
Investigators
Study Director: Microbia Medical Affairs Microbia, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00404001     History of Changes
Other Study ID Numbers: MCP-104-201
Study First Received: November 22, 2006
Last Updated: September 28, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Ironwood Pharmaceuticals, Inc.:
Microbia
MD-0727
Primary Hypercholesterolemia
Hypercholesterolemia
Hyperlipidemia
Dyslipidemia
Cholesterol
LDL

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014