A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia

Mixed Dyslipidemia Clinical Trial

Official title:

A Year 2, Long-Term, Open-Label, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00491530
• Other study ID #: M06-884
• Status: Completed
• Phase: Phase 3
• First received: June 22, 2007
• Last updated: January 18, 2012
• Start date: June 2007
• Est. completion date: November 2008

Study information

• Verified date: January 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to assess the continued safety of the daily coadministration of ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Subject has successfully completed the treatment phase of the preceding open-label year 1 study.

Exclusion Criteria:

• Subject is using or will use investigational medications, except as approved by Abbott.

• Subject has prematurely discontinued his/her combination therapy administered in the preceding open-label year 1 study.

Study Design

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

Related Conditions & MeSH terms

• Dyslipidemias
• Mixed Dyslipidemia

Intervention

Drug:
• ABT-335
Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
• rosuvastatin calcium
Oral coadministration of rosuvastatin calcium (20 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
• simvastatin
Oral coadministration of simvastatin (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study
• atorvastatin calcium
Oral coadministration of atorvastatin calcium (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study

Locations

Country	Name	City	State
United States	Medical Information Specialist	Abbott Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Reporting Adverse Events During Combination Therapy in the Preceding Double-Blind Studies or in the Preceding Open-Label Year 1 Study or in This Open-Label Year 2 Study	All serious and non-serious adverse events are reported from the time of combination study drug initiation until 30 days after discontinuation of study drug. Adverse events are unfavorable changes in health that occur in subjects during a clinical trial or within a specified period following a trial. Serious adverse events are those that result in death, require inpatient hospitalization or the prolongation of hospitalization, result in congenital anomaly/birth defect, or significant disability/incapacity or are life-threatening.	Anytime after initiation of combination therapy (in the preceding 12-week double-blind studies or in the preceding open-label year 1 study) up to 116 weeks, to within 30 days after the last dose of combination therapy.	Yes
Secondary	Median Percent Change in Triglycerides From Baseline to Week 104 of This Open-Label Year 2 Study	[(Week 104 triglycerides minus baseline triglycerides)/baseline triglycerides] X 100. Baseline is the last value prior to the first dose of combination therapy.	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)	No
Secondary	Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study	[(Week 104 HDL-C minus baseline HDL-C)/baseline HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)	No
Secondary	Mean Percent Change in Direct Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study	[(Week 104 LDL-C minus baseline LDL-C)/baseline LDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)	No
Secondary	Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study	[(Week 104 Non-HDL-C minus baseline Non-HDL-C)/baseline Non-HDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)	No
Secondary	Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Week 104 of This Open-Label Year 2 Study	[(Week 104 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] X 100. Baseline is the last value prior to the first dose of combination therapy.	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)	No
Secondary	Mean Percent Change in Total Cholesterol (Total-C) From Baseline to Week 104 of This Open-Label Year 2 Study	[(Week 104 Total-C minus baseline Total-C)/baseline Total-C] X 100. Baseline is the last value prior to the first dose of combination therapy.	Baseline to Week 104 (may include weeks in preceding double-blind studies [combination treatment arms], plus 52 weeks in preceding open-label year 1 study, and open-label year 2 study, up to 104 weeks)	No