Stress Echocardiography Study With Regadenoson - Full Text View

Sponsor:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00907764

Purpose

Regadenoson is approved in the US under the brand name Lexiscan for myocardial perfusion imaging. This study will test whether regadenoson is an appropriate stress agent for stress echocardiography.

Condition	Intervention	Phase
Heart Disease Coronary Artery Disease	Drug: regadenoson	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	An Open-Label, Parallel-Group, Exploratory Study to Evaluate the Efficacy and Safety of 400 ug Regadenoson Bolus for Pharmacological Stress Echocardiography

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Exercise and Physical Fitness Heart Diseases

Drug Information available for: CVT 3146

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Cardiac wall motion and perfusion abnormalities at rest and with regadenoson stress, with regadenoson stress and low level exercise, and with regadenoson stress and an echocontrast agent. [ Time Frame: Within 12 minutes after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Various safety data will be collected, including adverse events, heart and blood pressure levels, ECG data, clinical laboratory results, and concomitant medications. [ Time Frame: Up to day 29 after dosing ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	April 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Regadenoson alone	Drug: regadenoson 400 ug, IV
Experimental: Regadenoson with exercise	Drug: regadenoson 400 ug, IV
Experimental: Regadenoson with contrast agent	Drug: regadenoson 400 ug, IV
Experimental: Regadenoson with contrast agent (perfusion)	Drug: regadenoson 400 ug, IV

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with a clinically indicated dobutamine echocardiogram showing normal wall motion at rest and abnormal wall motion with stress
Patients with a clinically indicated dipyridamole echocardiogram showing normal perfusion and wall motion at rest and abnormal perfusion with or without abnormal wall motion with stress

Exclusion Criteria:

Any condition precluding the safe administration of dobutamine, dipyridamole or SonoVue for echocardiography
Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907764

Locations

United Kingdom
Northwick Park Hospital
Harrow, United Kingdom, HA1 3UJ

Sponsors and Collaborators

Gilead Sciences

Investigators

Principal Investigator:

Roxy Senior

Northwick Park Hospital

More Information

No publications provided

Responsible Party:	Peter Staehr, Senior Director, Clinical Pharmacology/Research, Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00907764 History of Changes
Other Study ID Numbers:	CVT 5127
Study First Received:	May 20, 2009
Last Updated:	July 14, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Regadenoson

Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012