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Cardiovascular and Torsades de Pointes Monitoring for Pazopanib

NCT01446224 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2015-03-27

No results posted yet for this study

Summary

This observational study is conducted as part of a systematic pharmacovigilance activity, to provide a population-based context for Pazopanib use outside of the clinical trial setting. The aims of the study are to examine the incidence of cardiovascular ischemia (including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident) and cardiac arrhythmia (Torsades de Pointes) in renal cell carcinoma patients treated with marketed anti-VEGF agents \[Pazopanib (VOTRIENT), Bevacizumab (AVASTIN), Sorafenib (NEXAVAR), and Sunitinib (SUTENT)\].

Two databases will be utilized for this study: a large healthcare claims database in the U.S. and the Dutch linked medical registries (PHARMO RLS). The databases will provide large, geographically varied, non-trial populations in which to examine the incidence of the stated cardiovascular ischemic events and Torsades des Pointes.

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Pazopanib

Patients treated with pazopanib

DRUG

Other anti-VEGFs

Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

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Companies

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 NCT01446224 on ClinicalTrials.gov