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

Abbott

Status and phase: Completed; Phase 3

Conditions: Mixed Dyslipidemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00491530

M06-884

Details and patient eligibility

About

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.

Enrollment: 310 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 3 patient groups

ABT-335 + rosuvastatin calcium

Experimental group

Treatment:

Drug: rosuvastatin calcium

Drug: ABT-335

ABT-335 + simvastatin

Experimental group

Treatment:

Drug: simvastatin

Drug: ABT-335

ABT-335 + atorvastatin calcium

Experimental group

Treatment:

Drug: ABT-335

Drug: atorvastatin calcium