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

Recruiting in Palo Alto (17 mi)

+167 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Torbjörn Lundström, MD

Principal Investigator

AstraZeneca

Eligibility Criteria

Inclusion Criteria

Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet.

Adult male and female participants who voluntarily sign the informed consent.

Triglycerides level greater than or equal to 150 mg/dL

Treatment Details

Interventions

• ABT-335 (Other)
• ABT-335 and rosuvastatin calcium (Other)
• rosuvastatin calcium (Other)

Participant Groups

Group I: ABT-335 and Rosuvastatin Calcium Experimental Treatment 1 Intervention

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

Group II: ABT-335 Active Control 1 Intervention

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

Group III: Rosuvastatin Calcium Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology