Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia

Treatments: Drug: ABT-143; Drug: simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00812955

M10-667

Details and patient eligibility

About

The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.

Full description

There are 4 treatment groups in the study: ABT-143 capsules 20/135 mg, ABT-143 capsules 10/135 mg, ABT-143 5/135 mg, and simvastatin capsules 40 mg. The primary outcome measure only compares 2 of these groups: ABT-143 capsules 20/135 mg and the simvastatin capsules 40 mg groups, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure . Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 10/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 10/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 5/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 5/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. For the other pre-specified outcome measures, median percent change in triglycerides from baseline to the final visit and mean percent change in HDL-C from baseline to the final visit for the full analysis sets, all 3 ABT-143 capsules 20/135 mg, 10/135 mg, and 5/135 mg groups were compared to the simvastatin capsules 40 mg group, therefore there are results for all 4 treatment groups for these outcome measures.

Enrollment: 474 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Participants with hypercholesterolemia and hypertriglyceridemia.

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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474 participants in 4 patient groups

A - ABT-143 capsules 5/135 mg

Experimental group

Description:

ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks

Treatment:

Drug: ABT-143

B - ABT-143 capsules 10/135 mg

Experimental group

Description:

ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks

Treatment:

Drug: ABT-143

C - ABT-143 capsules 20/135 mg

Experimental group

Description:

ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks

Treatment:

Drug: ABT-143

D - Simvastatin capsules 40 mg

Active Comparator group

Description:

Simvastatin capsules 40 mg daily for 8 weeks

Treatment:

Drug: simvastatin