Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides
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ClinicalTrials.gov Identifier: NCT00812955 |
Recruitment Status :
Completed
First Posted : December 22, 2008
Results First Posted : August 1, 2012
Last Update Posted : October 3, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia | Drug: ABT-143 Drug: simvastatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 474 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | An 8-Week, Multicenter, Randomized, Double-blind, Four-arm, Parallel-group Study Comparing the Safety and Efficacy of ABT-143 to Simvastatin in Subjects With Hypercholesterolemia |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: A - ABT-143 capsules 5/135 mg
ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
|
Drug: ABT-143
Once daily for 8 weeks |
Experimental: B - ABT-143 capsules 10/135 mg
ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
|
Drug: ABT-143
Once daily for 8 weeks |
Experimental: C - ABT-143 capsules 20/135 mg
ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
|
Drug: ABT-143
Once daily for 8 weeks |
Active Comparator: D - Simvastatin capsules 40 mg
Simvastatin capsules 40 mg daily for 8 weeks
|
Drug: simvastatin
Once daily for 8 weeks simvastatin capsules 40 mg |
- Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) [ Time Frame: Baseline to 8 weeks ]
The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups:
ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.
- Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) [ Time Frame: Baseline to 8 weeks ]The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.
- Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) [ Time Frame: Baseline to 8 weeks ]The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set.
- Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set) [ Time Frame: Baseline to 8 weeks ]The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for median percent change in triglycerides from Baseline to the Final Visit for the full analysis set.
- Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set) [ Time Frame: Baseline to 8 weeks ]The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for mean percent change in high-density lipoprotein cholesterol from Baseline to the Final Visit for the full analysis set.

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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
- Participants with hypercholesterolemia and hypertriglyceridemia.
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Participants had the following fasting lipid results following a greater than or equal to 12 hour fasting period (measured at the Screening Visit(s)):
- Triglycerides level greater than or equal to 150 milligrams/deciliter (mg/dL) and less than 400 milligrams/deciliter, and
- Low-density lipoprotein cholesterol greater than or equal to 160 milligrams/deciliter and less than or equal to 240 milligrams/deciliter.
Exclusion Criteria
- Participants with certain chronic or unstable medical conditions.
- Participants receiving coumarin anticoagulants, systemic cyclosporins, or certain other medications.
- Pregnant or lactating women, or women intending to become pregnant.
- Participants with diabetes mellitus that is poorly controlled.
- Participant was of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).

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 ClinicalTrials.gov identifier (NCT number): NCT00812955

Study Director: | Torbjörn Lundström, MD | AstraZeneca |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00812955 |
Other Study ID Numbers: |
M10-667 |
First Posted: | December 22, 2008 Key Record Dates |
Results First Posted: | August 1, 2012 |
Last Update Posted: | October 3, 2012 |
Last Verified: | September 2012 |
Dyslipidemia Hypercholesterolemia Hypertriglyceridemia |
Hypercholesterolemia Dyslipidemias Hypertriglyceridemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Simvastatin |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |