Phase 4
N=511
A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
Kidney Diseases · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00863707 ↗Enrolled (actual)
511
Serious AEs
0.2%
Results posted
Jan 2011
Primary outcome: Primary: Number of Subject With Serious Treatment Emergent Adverse Events (TEAE) — 0; 0 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Regadenoson (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Astellas Pharma Inc
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subject With Serious Treatment Emergent Adverse Events (TEAE) |
0; 0 | — |
Summary
This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00863707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.