A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment

Completed · Phase 4 · Has a placebo group

Conditions studied: Kidney Diseases, Coronary Artery Disease

In brief

This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.

Key facts

Study ID

NCT00863707

Run by

Astellas Pharma Inc

People needed

511

Starts

2009-04-01

Expected to finish

2009-12-01

Last updated by the study team

2012-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Anniston, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Bell Gardens, California, United States
• Study site — Fullerton, California, United States
• Study site — Garden Grove, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Oakland, California, United States
• Study site — Roseville, California, United States
• Study site — Santa Ana, California, United States
• Study site — Newark, Delaware, United States
• Study site — Wilmington, Delaware, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Trinity, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Ellijay, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Auburn, Maine, United States
• Study site — Detroit, Michigan, United States
• Study site — Flint, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Ridgewood, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.