Study of Oral MD-0727 Administered to Patients With Primary Hypercholesterolemia
This study has been completed.
Information provided by:
Ironwood Pharmaceuticals, Inc.
First received: November 22, 2006
Last updated: September 28, 2007
Last verified: September 2007
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- Low density lipoprotein cholesterol (LDL-C)
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00404001
Ironwood Pharmaceuticals, Inc.
||Microbia Medical Affairs
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 22, 2006
||September 28, 2007
||United States: Food and Drug Administration
Keywords provided by Ironwood Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Lipid Metabolism Disorders