Status:
COMPLETED
A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Kidney Diseases
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.
Eligibility Criteria
Inclusion
- Subject has a Stage III or Stage IV renal impairment based on the National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI) glomerular filtration rate (GFR) classification
- Subject has a diagnosis of Coronary Artery Disease (CAD) or risk factors for CAD as determined by a current medical diagnosis of at least 2 of the following conditions: Type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette smoking (minimum 10 pack-years exposure) or obesity (Body Mass Index (BMI) \> 30)
- Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration
- Subject must abstain from any intake of foods and beverages containing a methylated xanthine derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson
Exclusion
- Subject has a history of an additional clinically significant illness, medical condition, or laboratory abnormality within 2 weeks prior to Screening
- Female subject who is pregnant, lactating or of childbearing potential who refuses to use a medically acceptable form of contraception until the Follow-Up visit is complete
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT00863707
Start Date
April 1 2009
End Date
December 1 2009
Last Update
May 18 2012
Active Locations (41)
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1
Anniston, Alabama, United States, 36207
2
Little Rock, Arkansas, United States, 72204
3
Bell Gardens, California, United States, 90202
4
Fullerton, California, United States, 92835