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

May 11, 2012 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

511

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
    • California
      • Bell Gardens, California, United States, 90202
      • Fullerton, California, United States, 92835
      • Garden Grove, California, United States, 92845
      • Los Angeles, California, United States, 90017
      • Los Angeles, California, United States, 90022
      • Mission Viejo, California, United States, 92691
      • Oakland, California, United States, 94609
      • Roseville, California, United States, 95661
      • Santa Ana, California, United States, 92704
    • Delaware
      • Newark, Delaware, United States, 19713
      • Wilmington, Delaware, United States, 19808
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
      • Miami, Florida, United States, 33173
      • Orlando, Florida, United States, 32809
      • Trinity, Florida, United States, 34655
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Ellijay, Georgia, United States, 38540
    • Illinois
      • Chicago, Illinois, United States, 60616
    • Maine
      • Auburn, Maine, United States, 04210
    • Michigan
      • Detroit, Michigan, United States, 48202
      • Flint, Michigan, United States, 48504
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
      • Somerset, New Jersey, United States, 08873
    • New York
      • New York, New York, United States, 10010
      • Springfield Gardens, New York, United States, 11413
    • Ohio
      • Springfield, Ohio, United States, 45505
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
    • Oregon
      • Bend, Oregon, United States, 97701
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
      • Indiana, Pennsylvania, United States, 15701
      • Tyrone, Pennsylvania, United States, 16686
      • Wyomissing, Pennsylvania, United States, 19610
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Spartanburg, South Carolina, United States, 29303
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
    • Texas
      • Houston, Texas, United States, 77074
      • Houston, Texas, United States, 77055
      • Sugar Grove, Texas, United States, 77478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching intravenous (IV) bolus injection
Drug: Placebo
IV
Experimental: Regadenoson
0.4 mg/5 mL intravenous bolus injection
Drug: Regadenoson
IV
Other Names:
  • Lexiscan
  • CVT-3146

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)
Time Frame: 24 hours post dose

The data represents the numbers of subjects reporting Serious TEAEs.

TEAEs were defined as Adverse Events (AEs) starting or worsening after administration of the test drug.
24 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Central Contact, Astellas Pharma Global Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Estimate)

May 18, 2012

Last Update Submitted That Met QC Criteria

May 11, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3606-CL-3010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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