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A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

A Phase 4, Multicenter, Double-Blind, Randomized, Placebo-controlled Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment

NCT00863707•Astellas Pharma Inc

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (41)

Anniston, Alabama, United States

Little Rock, Arkansas, United States

Bell Gardens, California, United States

Fullerton, California, United States

Garden Grove, California, United States

Los Angeles, California, United States

Mission Viejo, California, United States

Oakland, California, United States

Roseville, California, United States

Key Dates

Start Date

April 1, 2009

Primary Completion Date

December 1, 2009

Completion Date

December 1, 2009

Last Updated

May 18, 2012

Enrollment

511

ACTUAL participants

Conditions

Kidney DiseasesCoronary Artery Disease

Interventions

Regadenoson

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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