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

Abbott

Status and phase: Completed; Phase 3

Conditions: Mixed Dyslipidemia; Coronary Heart Disease; Dyslipidemia

Treatments: Drug: ABT-335 and rosuvastatin calcium; Drug: ABT-335 and atorvastatin calcium; Drug: ABT-335 and simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00300430

M05-758

Details and patient eligibility

About

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.

Enrollment: 1,911 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,911 participants in 3 patient groups

A

Active Comparator group

Description:

20 mg drug and ABT-335

Treatment:

Drug: ABT-335 and rosuvastatin calcium

B

Active Comparator group

Description:

40 mg drug and ABT 335

Treatment:

Drug: ABT-335 and atorvastatin calcium

C

Active Comparator group

Description:

40 mg drug and ABT-335

Treatment:

Drug: ABT-335 and simvastatin