Trial Outcomes & Findings for A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment (NCT NCT00863707)

NCT ID: NCT00863707

Last Updated: 2012-05-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 511 participants
• Primary outcome timeframe: 24 hours post dose
• Results posted on: 2012-05-18

Participant Flow

Participant milestones

Measure	Placebo Matching intravenous (IV) bolus injection	Regadenoson 0.4 mg/5 mL intravenous bolus injection
Overall Study STARTED	174	337
Overall Study COMPLETED	170	334
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Placebo Matching intravenous (IV) bolus injection	Regadenoson 0.4 mg/5 mL intravenous bolus injection
Overall Study Randomized, but drug not received	4	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=170 Participants Matching intravenous (IV) bolus injection	Regadenoson n=334 Participants 0.4 mg/5 mL intravenous bolus injection	Total n=504 Participants Total of all reporting groups
Age Continuous	66.1 years STANDARD_DEVIATION 10.91 • n=5 Participants	66.4 years STANDARD_DEVIATION 11.25 • n=7 Participants	66.3 years STANDARD_DEVIATION 11.12 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	150 Participants n=7 Participants	228 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants	184 Participants n=7 Participants	276 Participants n=5 Participants
Race/Ethnicity, Customized White	115 participants n=5 Participants	254 participants n=7 Participants	369 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	47 participants n=5 Participants	68 participants n=7 Participants	115 participants n=5 Participants
Race/Ethnicity, Customized Asian	6 participants n=5 Participants	10 participants n=7 Participants	16 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian - Other Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours post dose

Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF); all randomized subjects who received any amount of study drug.

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.

Outcome measures

Measure	Placebo n=170 Participants Matching intravenous (IV) bolus injection	Regadenoson n=334 Participants 0.4 mg/5 mL intravenous bolus injection
Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)	0 Subjects	0 Subjects

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Regadenoson

Serious events: 0 serious events

Other events: 184 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=170 participants at risk Matching intravenous (IV) bolus injection	Regadenoson n=334 participants at risk 0.4 mg/5 mL intravenous bolus injection
Cardiac disorders Death	0.59% 1/170 • 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.	0.00% 0/334 • 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.

Other adverse events

Measure	Placebo n=170 participants at risk Matching intravenous (IV) bolus injection	Regadenoson n=334 participants at risk 0.4 mg/5 mL intravenous bolus injection
Nervous system disorders Headache	7.1% 12/170 • 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.	24.9% 83/334 • 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.
Nervous system disorders Dizziness	0.59% 1/170 • 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.	9.6% 32/334 • 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.
Nervous system disorders Dysgeusia	3.5% 6/170 • 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.	5.4% 18/334 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.59% 1/170 • 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.	19.2% 64/334 • 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.
Gastrointestinal disorders Nausea	1.2% 2/170 • 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.	14.7% 49/334 • 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.
General disorders Chest discomfort	0.59% 1/170 • 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.	14.7% 49/334 • 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.
Vascular disorders Flushing	1.8% 3/170 • 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.	12.0% 40/334 • 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.

Additional Information

Senior Medical Director, Medical Affairs

Astellas Pharma Global Development

Email: clinicaltrials@us.astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER