VCU-ART2: Anakinra to Prevent Adverse Post-infarction Remodeling (2)

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01175018
• Collaborator: American Heart Association (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac remodeling and heart failure.

The initial ischemic damage to the myocardium initiates an intense inflammatory response in promoting further cardiac dysfunction and heart failure. The investigators propose that an antiinflammatory strategy based on blockade of Interleukin-1 will quench the inflammatory response and lead to a more favorable cardiac remodeling process.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction; Heart Failure	Drug: Anakinra; Drug: Placebo	Phase 2

Detailed Description

Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality. Many patients die early during the course, and those who survive are at risk for dying late from adverse cardiac remodeling and heart failure.

The initial ischemic damage to the myocardium initiates an intense inflammatory response in promoting further cardiac dysfunction and heart failure. Interleukin-1 (IL-1) is the prototypical inflammatory cytokine involved in the tissue response to injury. In the experimental model of large anterior wall AMI in the mouse, IL-1 blockade using anakinra, a recombinant human IL-1 receptor antagonist ameliorates cardiac remodeling and improves survival following AMI. Although the mouse AMI model is helpful in understanding the events leading to adverse post-infarction cardiac remodeling and heart failure, the exact role of IL-1 in patients with AMI has not been completely characterized. The investigators propose to address this question by studying patients presenting with ST-segment elevation AMI (STEMI). Such patients are at high risk for in-hospital and long-term mortality and display several markers of inflammation. The investigators hypothesize that IL-1 blockade in patients STEMI with will limit the acute inflammatory response and prevent adverse cardiac remodeling, heart failure, and related morbidity.

The investigators hypothesize that treatment with anakinra will lead to more favorable cardiac remodeling. Left ventricular end-systolic volume index (LVESVi) is the preferred clinical marker of adverse cardiac remodeling and a strong predictor of heart failure-related mortality in patients with STEMI, and will be used as primary endpoint of the study. The investigators propose that anakinra will reduce the change in LVESVi from baseline to 10-14 weeks after STEMI, and will prevent, at least in part, other changes in cardiac function and exercise tolerance associated with adverse cardiac remodeling and heart failure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Anakinra to Prevent Adverse Post-infarction Remodeling (2)
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anakinra Anakinra 100 mg injectable subcutaneously daily	Drug: Anakinra; Anakinra 100 mg s.c. daily for 14 days; Other Names: Kineret
Placebo Comparator: Placebo 0.67 ml of sodium chloride (NaCl) 0.9% solution	Drug: Placebo; 0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days; Other Names: NaCl 0.9%

Outcome Measures

Primary Outcome Measures

1. Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices [10-14 weeks minus baseline]

   Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.

Secondary Outcome Measures

1. Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging [10-14 weeks]

2. Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%) [10-14 weeks]

3. Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks [10-14 weeks]

4. Incidence of Heart Failure [10-14 weeks]

   Difference between the anakinra arm and the placebo arm in number of patients with a new diagnosis or admission to the hospital for heart failure

5. Number of Adverse Events in Each Group [10-14 weeks]

6. Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF) [10-14 weeks]

7. Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging [10-14 weeks]

8. Median Difference Between the 2 Arms in the Ratio of Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) at 10-14 Weeks [10-14 weeks]

9. Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%) [10-14 weeks]

10. Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >5%) Based Upon Cardiac Magnetic Resonance Imaging [10-14 weeks]

11. Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >10%) [10-14 weeks]

12. Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5% [10-14 weeks]

13. Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10% [10-14 weeks]

14. Number of Deaths in Each Group [10-14 weeks]

15. Number of Adverse Events Requiring Withdrawal in Each Group [10-14 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 110 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with STEMI will be asked to enroll according to the following inclusion criteria:

• age > 18 years,

• acute (<12 h) onset of chest pain associated with ST segment elevation (>2 mm) in 2 or more anatomically contiguous leads at ECG,

• and successful primary percutaneous coronary intervention.

Exclusion criteria:

• inability to give informed consent,

• late presentation (>12 h),

• unsuccessful revascularization procedure,

• hemodynamic instability including hypotension,

• prior Q-wave AMI,

• end-stage congestive heart failure (American Heart Association [AHA]/American College of Cardiology [ACC] class C-D, New York Heart Association IV), severe left ventricular dysfunction (EF<20%),

• severe valvular heart disease,

• pregnancy, dye allergy or contraindications to cardiac angiography and/or magnetic resonance imaging, coagulopathy (INR>1.5 or platelet count<50000/mm3),

• recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs),

• chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), and malignancy or any comorbidity limiting survival or conditions predicting inability to complete the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University
• American Heart Association

Investigators

• Principal Investigator: Antonio Abbate, M.D., Ph.D., Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• VCU Pauley Heart Center

Publications

• Abbate A, Kontos MC, Grizzard JD, Biondi-Zoccai GG, Van Tassell BW, Robati R, Roach LM, Arena RA, Roberts CS, Varma A, Gelwix CC, Salloum FN, Hastillo A, Dinarello CA, Vetrovec GW; VCU-ART Investigators. Interleukin-1 blockade with anakinra to prevent adverse cardiac remodeling after acute myocardial infarction (Virginia Commonwealth University Anakinra Remodeling Trial [VCU-ART] Pilot study). Am J Cardiol. 2010 May 15;105(10):1371-1377.e1. doi: 10.1016/j.amjcard.2009.12.059. Epub 2010 Apr 2.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT01175018
• Other Study ID Numbers: AHA 10SDG3030051
• First Posted: Aug 4, 2010
• Last Update Posted: May 23, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Virginia Commonwealth University: Acute myocardial infarction; Heart Failure; Cardiac Remodeling
• Additional relevant MeSH terms: Heart Failure; Myocardial Infarction; Infarction; Interleukin 1 Receptor Antagonist Protein

Study Results

Participant Flow

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of sodium chloride (NaCl) 0.9% solution
Period Title: Overall Study
STARTED	15	15
COMPLETED	12	14
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Anakinra	Placebo	Total
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	11 73.3%	10 66.7%	21 70%
>=65 years	4 26.7%	5 33.3%	9 30%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (12)	58 (12)	59 (12)
Sex: Female, Male (Count of Participants)
Female	5 33.3%	2 13.3%	7 23.3%
Male	10 66.7%	13 86.7%	23 76.7%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-systolic Volume Indices
Description	Change in n left ventricular end-systolic volume indices from baseline to follow up exam at cardiac magnetic resonance imaging comparing anakinra- and placebo-treated patients.
Time Frame	10-14 weeks minus baseline

Outcome Measure Data

Analysis Population Description

Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	11	14
Median (Inter-Quartile Range) [mL/m2]	1.5	1.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

Title	Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular End-diastolic Volume Indices From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily Anakinra: Anakinra 100 mg s.c. daily for 14 days	0.67 ml of NaCl 0.9% solution Placebo: 0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days
Measure Participants	11	14
Median (Inter-Quartile Range) [mL/m2]	3	-4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANOVA
	Comments

3. Secondary Outcome

Title	Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >5%)
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	11	14
Number [% of participants]	45 300%	43 286.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

4. Secondary Outcome

Title	Median Difference Between the 2 Arms in the Peak Oxygen Consumption (VO2) at 10-14 Weeks
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	4	6
Median (Inter-Quartile Range) [ml*kg^-1*min^-1]	-1	2.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANOVA
	Comments

5. Secondary Outcome

Title	Incidence of Heart Failure
Description	Difference between the anakinra arm and the placebo arm in number of patients with a new diagnosis or admission to the hospital for heart failure
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	15	15
Number [participants]	1 6.7%	4 26.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Log Rank
	Comments

6. Secondary Outcome

Title	Number of Adverse Events in Each Group
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	15	15
Number [adverse events]	11	20

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

7. Secondary Outcome

Title	Difference Between the 2 Arm in the Interval Change in Right Ventricular Ejection Fraction (RVEF)
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	11	14
Median (Inter-Quartile Range) [% (absolute change)]	5	4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANOVA
	Comments

8. Secondary Outcome

Title	Difference Between the Anakinra Arm and the Placebo Arm in Change in Left Ventricular Ejection Fraction Values From Baseline to Follow up Exam at Cardiac Magnetic Resonance Imaging
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	11	14
Median (Inter-Quartile Range) [% (absolute change)]	2	-2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANOVA
	Comments

9. Secondary Outcome

Title	Median Difference Between the 2 Arms in the Ratio of Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) at 10-14 Weeks
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	4	6
Median (Inter-Quartile Range) [(no units; ratio of values)]	-1	-3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANOVA
	Comments

10. Secondary Outcome

Title	Percentage of Patients in Each Group With Reverse Remodeling (Reduction in LVESVi >10%)
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	11	14
Number [% of participants]	27 180%	36 240%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

11. Secondary Outcome

Title	Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >5%) Based Upon Cardiac Magnetic Resonance Imaging
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

Applies only to subset of patients with magnetic resonance imaging (MRI) at baseline and 10-14 weeks.

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	11	14
Number [% of participants]	55 366.7%	42 280%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

12. Secondary Outcome

Title	Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >10%)
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	11	14
Number [% of participants]	45 300%	29 193.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

13. Secondary Outcome

Title	Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5%
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	11	14
Number [% of participants]	36 240%	36 240%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

14. Secondary Outcome

Title	Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10%
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	11	14
Number [% of participants]	27 180%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

15. Secondary Outcome

Title	Number of Deaths in Each Group
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	15	15
Number [deaths]	0	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

16. Secondary Outcome

Title	Number of Adverse Events Requiring Withdrawal in Each Group
Time Frame	10-14 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily	0.67 ml of NaCl 0.9% solution
Measure Participants	15	15
Number [adverse events]	2	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Anakinra, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Anakinra		Placebo
Arm/Group Description	Anakinra 100 mg injectable subcutaneously daily		0.67 ml of NaCl 0.9% solution
All Cause Mortality
	Anakinra		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Anakinra		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/15 (26.7%)		6/15 (40%)
Cardiac disorders
Death	0/15 (0%)	0	1/15 (6.7%)	1
New onset heart failure	1/15 (6.7%)	1	4/15 (26.7%)	4
Recurrent myocardial infarction or repeat percutaneous coronary intervention	1/15 (6.7%)	1	1/15 (6.7%)	1
Left ventricular thrombus	0/15 (0%)	0	1/15 (6.7%)	1
Cardiac rupture	0/15 (0%)	0	1/15 (6.7%)	1
Infections and infestations
Serious infection	2/15 (13.3%)	2	2/15 (13.3%)	2
Other (Not Including Serious) Adverse Events
	Anakinra		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/15 (40%)		8/15 (53.3%)
Blood and lymphatic system disorders
Bleeding (not serious)	1/15 (6.7%)	1	4/15 (26.7%)	4
Eosinophilia	0/15 (0%)	0	1/15 (6.7%)	1
Thrombocytopenia	1/15 (6.7%)	1	0/15 (0%)	0
Cardiac disorders
Presyncope	0/15 (0%)	0	1/15 (6.7%)	1
Infections and infestations
Infection (not serious)	2/15 (13.3%)	2	0/15 (0%)	0
Renal and urinary disorders
Hyperkalemia	0/15 (0%)	0	1/15 (6.7%)	1
Urinary retention	0/15 (0%)	0	1/15 (6.7%)	1
Skin and subcutaneous tissue disorders
Injection site pain	3/15 (20%)	3	2/15 (13.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.