30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Dyslipidemia; Kidney Disease

Treatments: Drug: Rosuvastatin; Drug: ABT-335 plus rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00680017

M10-313

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Dyslipidemic participants with Chronic Kidney Disease Stage 3

• For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit[s]):

  • Estimated glomerular filtration rate between 30 and 59 mL/min/1.73 m2 (Chronic Kidney Disease Stage 3) by simplified 4 variable Modification of Diet in Renal Disease formula (this includes a 10 percent variation in the upper limit of estimated glomerular filtration rate that was allowed for the enrollment of participants to account for variability in the creatinine assay).
  • Fasting lipid results following greater than or equal to 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 Exclusion Criteria

• Participants with certain chronic or unstable medical conditions.

• Participants with unstable dose of medications or receiving coumarin anticoagulants, systemic cyclosporine, or certain other medications.

• Pregnant or lactating women, or women intending to become pregnant.

• Participants with diabetes mellitus that is poorly controlled.

• Participants 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: Quadruple Blind

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280 participants in 2 patient groups

ABT-335 plus rosuvastatin

Experimental group

Description:

ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks

Treatment:

Drug: ABT-335 plus rosuvastatin

Rosuvastatin

Active Comparator group

Description:

Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks

Treatment:

Drug: Rosuvastatin