A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
This study has been completed.
Sponsor:
Esperion Therapeutics
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT01262638
First received: December 16, 2010
Last updated: November 29, 2011
Last verified: November 2011
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Purpose
This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.
| Condition | Intervention | Phase |
|---|---|---|
|
Dyslipidemia |
Drug: ETC-1002 Drug: Placebo |
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 Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002 in Subjects With Hypercholesterolemia and Either Normal or Elevated Triglycerides. |
Resource links provided by NLM:
Further study details as provided by Esperion Therapeutics:
Primary Outcome Measures:
- To assess the LDL-C lowering efficacy of ETC-1002 versus placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the efficacy of ETC-1002 to modulate TG and other lipid and cardio-metabolic biomarkers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 177 |
| Study Start Date: | December 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ETC-1002 120 mg (Group 1)
Subjects with hypercholesterolemia and normal triglycerides
|
Drug: ETC-1002
Daily for 12 weeks
|
|
Experimental: ETC-1002 80 mg (Group 2)
Subjects with hypercholesterolemia and normal triglycerides
|
Drug: ETC-1002
Daily for 12 weeks
|
|
Experimental: ETC-1002 40 mg (Group 3)
Subjects with hypercholesterolemia and normal triglycerides
|
Drug: ETC-1002
Daily for 12 weeks
|
|
Experimental: Placebo (Group 4)
Subjects with hypercholesterolemia and normal triglycerides
|
Drug: Placebo
ETC-1002 40 mg, 80 mg, and 120 mg versus placebo
|
|
Experimental: ETC-1002 120 mg (Group 5)
Subjects with hypercholesterolemia and elevated triglycerides
|
Drug: ETC-1002
Daily for 12 weeks
|
|
Experimental: ETC-1002 80 mg (Group 6)
Subjects with hypercholesterolemia and elevated triglycerides
|
Drug: ETC-1002
Daily for 12 weeks
|
|
Experimental: ETC-1002 40 mg (Group 7)
Subjects with hypercholesterolemia and elevated triglycerides
|
Drug: ETC-1002
Daily for 12 weeks
|
|
Experimental: Placebo (Group 8)
Subjects with hypercholesterolemia and elevated triglycerides
|
Drug: Placebo
ETC-1002 40 mg, 80 mg, and 120 mg versus placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Major Inclusion Criteria:
- Provision of written informed consent prior to any study-specific procedure
- Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating medications and supplements
- Fasting triglyceride <400 mg/dL following wash-out of all lipid regulating medications and supplements
- BMI between 18 and 35 mg/kg2
Major Exclusion Criteria:
- Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension
- Females of child bearing potential (i.e., females who are not surgically sterile or post-menopausal)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262638
Locations
| United States, Arizona | |
| Chandler, Arizona, United States, 85225 | |
| United States, California | |
| Greenbrae, California, United States, 94904 | |
| Santa Rosa, California, United States, 95405 | |
| United States, Florida | |
| Jacksonville, Florida, United States, 32216 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60654 | |
| United States, Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kentucky | |
| Louisville, Kentucky, United States, 40213 | |
| United States, Michigan | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, North Carolina | |
| Raleigh, North Carolina, United States, 27609 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Richmond, Virginia, United States, 23294 | |
Sponsors and Collaborators
Esperion Therapeutics
More Information
No publications provided
| Responsible Party: | Esperion Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01262638 History of Changes |
| Other Study ID Numbers: | ETC-1002-003 |
| Study First Received: | December 16, 2010 |
| Last Updated: | November 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013