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Sponsored by: |
Ironwood Pharmaceuticals, Inc. |
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Information provided by: | Ironwood Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00404001 |
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 |
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Hypercholesterolemia |
Drug: MD-0727 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Microbia Medical Affairs | Microbia, Inc. |
Study ID Numbers: | MCP-104-201 |
Study First Received: | November 22, 2006 |
Last Updated: | September 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00404001 |
Health Authority: | United States: Food and Drug Administration |
Microbia MD-0727 Primary Hypercholesterolemia Hypercholesterolemia |
Hyperlipidemia Dyslipidemia Cholesterol LDL |
Signs and Symptoms Metabolic Diseases Hyperlipidemias Metabolic disorder |
Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |