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This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching intravenous (IV) bolus injection |
|
| Regadenoson | Experimental | 0.4 mg/5 mL intravenous bolus injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson | Drug | IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subject With Serious Treatment Emergent Adverse Events (TEAE) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston | Alabama | 36207 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22259009 | Background | Ananthasubramaniam K, Weiss R, McNutt B, Klauke B, Feaheny K, Bukofzer S. A randomized, double-blind, placebo-controlled study of the safety and tolerance of regadenoson in subjects with stage 3 or 4 chronic kidney disease. J Nucl Cardiol. 2012 Apr;19(2):319-29. doi: 10.1007/s12350-011-9508-3. Epub 2012 Jan 19. |
| Label | URL |
|---|---|
| Link to Prescribing Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching intravenous (IV) bolus injection |
| FG001 | Regadenoson | 0.4 mg/5 mL intravenous bolus injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | IV |
|
| Little Rock |
| Arkansas |
| 72204 |
| United States |
| Bell Gardens | California | 90202 | United States |
| Fullerton | California | 92835 | United States |
| Garden Grove | California | 92845 | United States |
| Los Angeles | California | 90017 | United States |
| Los Angeles | California | 90022 | United States |
| Mission Viejo | California | 92691 | United States |
| Oakland | California | 94609 | United States |
| Roseville | California | 95661 | United States |
| Santa Ana | California | 92704 | United States |
| Newark | Delaware | 19713 | United States |
| Wilmington | Delaware | 19808 | United States |
| Fort Lauderdale | Florida | 33308 | United States |
| Miami | Florida | 33173 | United States |
| Orlando | Florida | 32809 | United States |
| Trinity | Florida | 34655 | United States |
| Winter Park | Florida | 32789 | United States |
| Ellijay | Georgia | 38540 | United States |
| Chicago | Illinois | 60616 | United States |
| Auburn | Maine | 04210 | United States |
| Detroit | Michigan | 48202 | United States |
| Flint | Michigan | 48504 | United States |
| Minneapolis | Minnesota | 55415 | United States |
| Ridgewood | New Jersey | 07450 | United States |
| Somerset | New Jersey | 08873 | United States |
| New York | New York | 10010 | United States |
| Springfield Gardens | New York | 11413 | United States |
| Springfield | Ohio | 45505 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Bend | Oregon | 97701 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Indiana | Pennsylvania | 15701 | United States |
| Tyrone | Pennsylvania | 16686 | United States |
| Wyomissing | Pennsylvania | 19610 | United States |
| Charleston | South Carolina | 29425 | United States |
| Spartanburg | South Carolina | 29303 | United States |
| Knoxville | Tennessee | 37920 | United States |
| Houston | Texas | 77055 | United States |
| Houston | Texas | 77074 | United States |
| Sugar Grove | Texas | 77478 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching intravenous (IV) bolus injection |
| BG001 | Regadenoson | 0.4 mg/5 mL intravenous bolus injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subject With Serious Treatment Emergent Adverse Events (TEAE) | 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. | The number of participants analyzed per arm represents Safety Analysis Set (SAF); all randomized subjects who received any amount of study drug. | Posted | Number | Subjects | 24 hours post dose |
|
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|
Adverse Event collection began immediately following study drug administration through the follow-up visit. All Serious Adverse Events (SAEs) occurring until 30 days after dosing were reported.
TEAEs were defined as AEs starting or worsening after starting administration of the test drug.
Within a system organ class subjects may have reported more than one type of Adverse Event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching intravenous (IV) bolus injection | 1 | 170 | 20 | 170 | ||
| EG001 | Regadenoson | 0.4 mg/5 mL intravenous bolus injection | 0 | 334 | 184 | 334 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | MedDRA (11.1) | Systematic Assessment | SAE Investigator Reported Term "Pulmonary Cardiac Arrest" coded to "Death" was reported after the follow-up visit. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
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Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Director, Medical Affairs | Astellas Pharma Global Development | clinicaltrials@us.astellas.com |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D003324 | Coronary Artery Disease |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C430916 | regadenoson |
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| Male |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian - Other Pacific Islander |
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| Other |
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