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Completed

NCT Number: NCT00680017

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 24402, Carolina, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ABT-335 plus rosuvastatin

Drug

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

Other names: fenofibric acid and rosuvastatin

Rosuvastatin

Drug

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

Other names: rosuvastatin, Crestor

Primary outcomes

  1. Median Percent Change in Triglycerides From Baseline to Week 8.

    Time frame: Baseline to 8 weeks

    Triglycerides were measured in milligrams/deciliter.

Secondary outcomes

  1. Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.

    Time frame: Baseline to 8 weeks

    High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects With Stage 3 Chronic Kidney Disease

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 19, 2008
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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