Skip to main content
OpenTrials
Completed

NCT Number: NCT00300430

Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.

The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyslipidemia Cardiovascular Diseases Coronary Disease Coronary Heart Disease Dyslipidemias Heart Diseases Lipid Metabolism Disorders Metabolic Diseases Mixed Dyslipidemia Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Global Medical Information

North Chicago, Illinois, 60064, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult male and female subjects who voluntarily sign the informed consent.
  • Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies.

Exclusion criteria

  • Subject is using or will use investigational medications, except as approved by Abbott.
  • Subject has prematurely discontinued his/her initial therapy one of the prior ABT-335, rosuvastatin, simvastatin and atorvastatin calcium combination therapy studies.

Treatment and study plan

ABT-335 and rosuvastatin calcium

Drug

ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks

Other names: ABT-335, TRILIPIX

ABT-335 and atorvastatin calcium

Drug

ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks

Other names: ABT-335, TRILIPIX

ABT-335 and simvastatin

Drug

ABT-335 135 mg plus simvastatin daily, 52 weeks

Other names: ABT-335, TRILIPIX

Primary outcomes

  1. Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-blind Studies or in This Open-label Study

    Time frame: Anytime after initiation of combination therapy (either in the double-blind or open-label study) to within 30 days after the last dose of combination therapy

Secondary outcomes

  1. Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-label Study

    Time frame: Baseline to Week 52 of the open-label study

  2. Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-label Study

    Time frame: Baseline to Week 52 of the open-label study

  3. Mean Percent Change in Direct Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-label Study

    Time frame: Baseline to Week 52 of the open-label study

  4. Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-label Study

    Time frame: Baseline to Week 52 in this open-label study

  5. Mean Percent Change in Very Low-density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-label Study

    Time frame: Baseline to Week 52 of the open-label study

  6. Mean Percent Change in Total Cholesterol From Baseline to Week 52 of the Open-label Study

    Time frame: Baseline to Week 52 of the open-label study

  7. Mean Percent Change in Apolipoprotein B (Apo B) From Baseline to Week 52 of the Open-label Study

    Time frame: Baseline to Week 52 of the open-label study

  8. Median Percent Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 52 of the Open-label Study

    Time frame: Baseline to Week 52 of the open-label study

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects With Mixed Dyslipidemia

Important dates

Study start
2006
Primary completion
2008
First posted
Mar 9, 2006
Registry last updated
Jul 23, 2009

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.