A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia

NCT00463606 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 760

Last updated 2012-10-03

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.

Conditions

Interventions

DRUG

ABT-335 and rosuvastatin calcium

ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks

DRUG

ABT-335

ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks

DRUG

rosuvastatin calcium

Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Torbjörn Lundström, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00463606 on ClinicalTrials.gov