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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863707
Recruitment Status : Completed
First Posted : March 18, 2009
Results First Posted : January 31, 2011
Last Update Posted : May 18, 2012
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Kidney Diseases Coronary Artery Disease Drug: Regadenoson Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 511 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: A Phase 4, Multicenter, Double-Blind, Randomized, Placebo-controlled Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
Study Start Date : April 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Regadenoson

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:
  • CVT-3146
  • Lexiscan




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863707


Locations
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United States, Alabama
Anniston, Alabama, United States, 36207
United States, Arkansas
Little Rock, Arkansas, United States, 72204
United States, 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
United States, Delaware
Newark, Delaware, United States, 19713
Wilmington, Delaware, United States, 19808
United States, 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
United States, Georgia
Ellijay, Georgia, United States, 38540
United States, Illinois
Chicago, Illinois, United States, 60616
United States, Maine
Auburn, Maine, United States, 04210
United States, Michigan
Detroit, Michigan, United States, 48202
Flint, Michigan, United States, 48504
United States, Minnesota
Minneapolis, Minnesota, United States, 55415
United States, New Jersey
Ridgewood, New Jersey, United States, 07450
Somerset, New Jersey, United States, 08873
United States, New York
New York, New York, United States, 10010
Springfield Gardens, New York, United States, 11413
United States, Ohio
Springfield, Ohio, United States, 45505
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Bend, Oregon, United States, 97701
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
Indiana, Pennsylvania, United States, 15701
Tyrone, Pennsylvania, United States, 16686
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Charleston, South Carolina, United States, 29425
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Knoxville, Tennessee, United States, 37920
United States, Texas
Houston, Texas, United States, 77055
Houston, Texas, United States, 77074
Sugar Grove, Texas, United States, 77478
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Central Contact Astellas Pharma Global Development
Additional Information:
Publications:
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00863707    
Other Study ID Numbers: 3606-CL-3010
First Posted: March 18, 2009    Key Record Dates
Results First Posted: January 31, 2011
Last Update Posted: May 18, 2012
Last Verified: May 2012
Keywords provided by Astellas Pharma Inc:
regadenoson
chronic kidney disease stage III
chronic kidney disease stage IV
renal impairment
coronary artery disease
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Urologic Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Regadenoson
Adenosine A2 Receptor Agonists
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs