A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia; Dyslipidemia

Treatments: Drug: ABT-335; Drug: rosuvastatin calcium; Drug: ABT-335 and rosuvastatin calcium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00463606

M06-844

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.

Full description

There are 3 treatment groups in the study: ABT-335 135 mg in combination with rosuvastatin 5 mg, ABT-335 135 mg monotherapy, and rosuvastatin 5 mg monotherapy. The 3 primary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in HDL-C and TG comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and mean percent change in LDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy. The 6 secondary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in Non-HDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy, mean percent change in Non-HDL-C, VLDL-C, ApoB, and Total Cholesterol comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and median percent change in hsCRP comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy).

Enrollment: 760 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Adult male and female participants who voluntarily sign the informed consent.

• Fasting lipid results following greater than 12-hour fasting period:

  • Triglycerides level greater than or equal to 150 mg/dL,
  • High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and
  • Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL.

• Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet.

Exclusion Criteria

• Participants with unstable medical conditions, medical conditions considered inappropriate in a clinical trial, or participants who are taking excluded concomitant medications are not allowed in the study.
• Participants receiving coumarin anticoagulants or systemic cyclosporine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

760 participants in 3 patient groups

ABT-335 and Rosuvastatin Calcium

Experimental group

Description:

ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks

Treatment:

Drug: ABT-335 and rosuvastatin calcium

ABT-335

Active Comparator group

Description:

ABT-335 135mg monotherapy administered orally, once daily for 12 weeks

Treatment:

Drug: ABT-335

Rosuvastatin Calcium

Active Comparator group

Description:

Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks

Treatment:

Drug: rosuvastatin calcium