DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dyslipidemia; Coronary Heart Disease; Mixed Dyslipidemia

Intervention: ABT-335 and rosuvastatin calcium (Drug); ABT-335 and atorvastatin calcium (Drug); ABT-335 and simvastatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Subjects Reporting Adverse Events During Combination Therapy, Either in the Preceding Double-Blind Studies or in This Open-Label Study

Secondary outcome:

Median Percent Change in Triglycerides From Baseline to Week 52 of the Open-Label Study

Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52 of the Open-Label Study

Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 of the Open-Label Study

Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 52 in This Open-Label Study

Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 52 of the Open-Label Study

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

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

Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Week 52 of the Open-Label Study

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Global Medical Information, North Chicago, Illinois 60064, United States
Additional Information

Starting date: September 2006
Last updated: June 3, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017