Trial Outcomes & Findings for CAndesartan vs LIsinopril Effects on the BRain (NCT NCT01984164)
NCT ID: NCT01984164
Last Updated: 2021-02-21
Results Overview
Executive function will be assessed using Trail Making Test (part B-A). Part A was collected to correct for motor speed and visual-perceptual demands on TMT by subtracting completion time for TMT Part A from completion time for Part B (TMT B - A). TMT Part B-A provides a relatively purer measure of executive functioning. It has a timed scale from 0 sec (min) to 300 secs (max). Along this scale, a lower score is better.
COMPLETED
PHASE2
176 participants
12 months
2021-02-21
Participant Flow
Participant milestones
| Measure |
Candesartan
To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Candesartan: blinded
|
Lisinopril
To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Lisinopril: Blinded
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
89
|
|
Overall Study
COMPLETED
|
77
|
64
|
|
Overall Study
NOT COMPLETED
|
10
|
25
|
Reasons for withdrawal
| Measure |
Candesartan
To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Candesartan: blinded
|
Lisinopril
To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Lisinopril: Blinded
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Adverse Event
|
5
|
19
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
CAndesartan vs LIsinopril Effects on the BRain
Baseline characteristics by cohort
| Measure |
Candesartan
n=87 Participants
To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Candesartan: blinded
|
Lisinopril
n=89 Participants
To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Lisinopril: Blinded
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 8.3 • n=93 Participants
|
65.8 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
65.9 years
STANDARD_DEVIATION 8.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
101 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
56 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
113 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
87 participants
n=93 Participants
|
89 participants
n=4 Participants
|
176 participants
n=27 Participants
|
|
MoCA score
|
21.4 points
STANDARD_DEVIATION 3.4 • n=93 Participants
|
21.7 points
STANDARD_DEVIATION 3.5 • n=4 Participants
|
21.5 points
STANDARD_DEVIATION 3.4 • n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsExecutive function will be assessed using Trail Making Test (part B-A). Part A was collected to correct for motor speed and visual-perceptual demands on TMT by subtracting completion time for TMT Part A from completion time for Part B (TMT B - A). TMT Part B-A provides a relatively purer measure of executive functioning. It has a timed scale from 0 sec (min) to 300 secs (max). Along this scale, a lower score is better.
Outcome measures
| Measure |
Candesartan
n=87 Participants
To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Candesartan: blinded
|
Lisinopril
n=89 Participants
To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Lisinopril: Blinded
|
|---|---|---|
|
Executive Function
|
87.23 seconds
Standard Error 5.46
|
111.37 seconds
Standard Error 5.89
|
PRIMARY outcome
Timeframe: 12 monthsEXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or "EXAMINER" tool box. This test batteryThe battery includes 11 tasks that generate 15 primary variables. Within this set, the EXAMINER includes: working memory, inhibition, set shifting, and fluency. The parts of EXAMINER that were used for this study include: Flanker task (inhibition) which involves responding to a central stimulus while ignoring flanking stimuli that are either compatible or incompatible with the central stimulus; Set-shifting, a measure of mental flexibility; Spatial 1-Back test assesses spatial working memory; Dot Counting test assesses verbal working memory; Verbal Fluency tested using a List Generation test which require the participant to generate words beginning with a specific letter, and category fluency in which the participant generates words from a specified category (e.g., animals, fruits). Higher are reflective of better executive function (-1 to +1)
Outcome measures
| Measure |
Candesartan
n=87 Participants
To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Candesartan: blinded
|
Lisinopril
n=89 Participants
To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Lisinopril: Blinded
|
|---|---|---|
|
NINDS-initiated EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or "EXAMINER" Tool Box.
|
0.07 units on a scale
Standard Error 0.07
|
0.25 units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 12 monthsTo assess episodic memory, the Hopkins Verbal Learning Test-Revised (HVLT-R) will be used. The retention (%) score is calculated by dividing the delayed recall trial by the higher of 3 learning trials. Each trial scores 0 (min) to 12 (max). The HVLT-R retention score is a percentage, and a higher percentage represents a better outcome.
Outcome measures
| Measure |
Candesartan
n=87 Participants
To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Candesartan: blinded
|
Lisinopril
n=89 Participants
To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Lisinopril: Blinded
|
|---|---|---|
|
Memory
|
82.71 percentage of retention
Standard Error 3.26
|
79.47 percentage of retention
Standard Error 3.39
|
SECONDARY outcome
Timeframe: 12 monthsThis will be measured using the Boston Naming Test. BNT is a neuropsychological test used to assess visual confrontation naming and language performance in participants with cognitive decline. Its short 15-item version consists of drawings of objects ranging from common objects to less familiar objects. Scale: 0 (min score) to 15 (max score). For this test, a higher score/response represents a better outcome.
Outcome measures
| Measure |
Candesartan
n=87 Participants
To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Candesartan: blinded
|
Lisinopril
n=89 Participants
To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Lisinopril: Blinded
|
|---|---|---|
|
Language
|
13.42 number of correct responses
Standard Error 0.18
|
13.84 number of correct responses
Standard Error 0.18
|
SECONDARY outcome
Timeframe: 12 monthsThe Digit Span test is a subtest of both the Wechsler Adult Intelligence Scale (WAIS) and the Wechsler Memory Scales (WMS). For the digit span backwards, subjects are read a sequence of numbers and asked to repeat the same sequence back to the examiner in reverse order (backward span). Backward span is an executive task particularly dependent on working memory. The Digit Span backward is scored for backwards performance. Scale: 0 (minimum) to 16 (maximum). A higher score represents a better outcome.
Outcome measures
| Measure |
Candesartan
n=87 Participants
To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Candesartan: blinded
|
Lisinopril
n=89 Participants
To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Lisinopril: Blinded
|
|---|---|---|
|
Attention Measured Using Digit Span Backward
|
5.14 Number of correct responses
Standard Error 0.25
|
5.16 Number of correct responses
Standard Error 0.26
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Of 176 randomized participants, 27 did not complete an MRI scan at baseline (15 had metal implants with either pacemaker, stent, or inferior vena cava filter and 12 were claustrophobic). Of 141 participants who returned for their 12-month visit, an additional 8 participants refused to have a follow-up MRI. The final sample with both baseline and 12-month MRI was 104 participants (73.8%), including 51 participants in the candesartan group and 53 participants in the lisinopril group.
White Matter Lesion volume: high-resolution anatomical images are acquired for the measurement of microvascular disease. WMH volumes will be obtained from Fluid attenuated inversion recovery (FLAIR) imaging sequence and reported as total volume (in mm3). Higher values means greater WMH
Outcome measures
| Measure |
Candesartan
n=51 Participants
To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Candesartan: blinded
|
Lisinopril
n=53 Participants
To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Lisinopril: Blinded
|
|---|---|---|
|
White Matter Lesion Volume
|
2.68 mm^3
Standard Error 1.23
|
5.73 mm^3
Standard Error 1.22
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Of 176 randomized participants, 27 did not complete an MRI scan at baseline (15 had metal implants with either pacemaker, stent, or inferior vena cava filter and 12 were claustrophobic). Of 141 participants who returned for their 12-month visit, an additional 8 participants refused to have a follow-up MRI. The final sample with both baseline and 12-month MRI was 104 participants (73.8%), including 51 participants in the candesartan group and 53 participants in the lisinopril group.
ASL-MRI: Arterial Spin Labeling (ASL) MRI is non-invasive measure of perfusion that does not require contrast, and allows multiple brain regions mapping of perfusion and reserve. ASL-MRI provides measures of cerebral blood flow (CBF). Higher values indicates higher CBF.
Outcome measures
| Measure |
Candesartan
n=51 Participants
To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Candesartan: blinded
|
Lisinopril
n=53 Participants
To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Lisinopril: Blinded
|
|---|---|---|
|
Cerebral Perfusion
|
45.48 ml/100g/min
Standard Error 1.47
|
47.65 ml/100g/min
Standard Error 1.08
|
SECONDARY outcome
Timeframe: 12 monthsThis will be measured using Digit Span Forward. The Digit Span test is a subtest of both the Wechsler Adult Intelligence Scale (WAIS) and the Wechsler Memory Scales (WMS). For the digit span forward, subjects are read a sequence of numbers and asked to repeat the same sequence back to the examiner in the correct order (forward span). Forward span captures attention efficiency and capacity. The Digit Span forward is scored for forwards performance. Scale: 0 (minimum) to 16 (maximum). A higher score represents a better outcome.
Outcome measures
| Measure |
Candesartan
n=87 Participants
To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Candesartan: blinded
|
Lisinopril
n=89 Participants
To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Lisinopril: Blinded
|
|---|---|---|
|
Attention Measured Using Digit Span Forward
|
9.67 Number of correct responses
Standard Error 0.61
|
8.93 Number of correct responses
Standard Error 0.66
|
Adverse Events
Candesartan
Lisinopril
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Candesartan
n=87 participants at risk
To achieve blood pressure control, we will use a stepwise protocol as follows: candesartan (blinded) 8mg→ 16mg→ 32mg. Both groups will also receive (unblinded) , if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg →10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Candesartan: blinded
|
Lisinopril
n=89 participants at risk
To achieve blood pressure control we will use a stepwise protocol as follows: lisinopril (blinded) 10mg→ 20mg→ 40mg. Both groups will also receive (unblinded), if needed to achieve blood pressure control, HCTZ 12.5mg→ 25mg, Amlodipine 2.5mg→ 5mg→ 10mg and metoprolol succinate extended release 12.5mg→ 25mg→ 50mg. Antihypertensive medications will be increased every 2 weeks until control is achieved.
Lisinopril: Blinded
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
7/87 • Number of events 7 • 12 months
|
27.0%
24/89 • Number of events 24 • 12 months
|
|
General disorders
Headache
|
20.7%
18/87 • Number of events 18 • 12 months
|
24.7%
22/89 • Number of events 22 • 12 months
|
|
General disorders
Dizziness
|
17.2%
15/87 • Number of events 15 • 12 months
|
15.7%
14/89 • Number of events 14 • 12 months
|
|
General disorders
Edema
|
14.9%
13/87 • Number of events 13 • 12 months
|
13.5%
12/89 • Number of events 12 • 12 months
|
|
General disorders
General Pain
|
8.0%
7/87 • Number of events 7 • 12 months
|
10.1%
9/89 • Number of events 9 • 12 months
|
|
General disorders
Fatigue
|
10.3%
9/87 • Number of events 9 • 12 months
|
7.9%
7/89 • Number of events 7 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/sinus drainage
|
1.1%
1/87 • Number of events 1 • 12 months
|
6.7%
6/89 • Number of events 6 • 12 months
|
|
Cardiac disorders
Palpitation
|
4.6%
4/87 • Number of events 4 • 12 months
|
4.5%
4/89 • Number of events 4 • 12 months
|
|
Renal and urinary disorders
Frequent urination
|
4.6%
4/87 • Number of events 4 • 12 months
|
3.4%
3/89 • Number of events 3 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
1.1%
1/87 • Number of events 1 • 12 months
|
2.2%
2/89 • Number of events 2 • 12 months
|
|
General disorders
Insomnia
|
0.00%
0/87 • 12 months
|
2.2%
2/89 • Number of events 2 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
2.3%
2/87 • Number of events 2 • 12 months
|
2.2%
2/89 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Unusual bleeding or bruising
|
0.00%
0/87 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
General disorders
Falling
|
3.4%
3/87 • Number of events 3 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
General disorders
Dry mouth
|
1.1%
1/87 • Number of events 1 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/87 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Loss of appetite
|
0.00%
0/87 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
2.3%
2/87 • Number of events 2 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/87 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/87 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
Vascular disorders
Severe elevation in systolic BP >200 mmHg
|
0.00%
0/87 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.2%
8/87 • Number of events 8 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.1%
1/87 • Number of events 1 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.1%
1/87 • Number of events 1 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
General disorders
Sweating
|
0.00%
0/87 • 12 months
|
1.1%
1/89 • Number of events 1 • 12 months
|
|
General disorders
Fainting
|
1.1%
1/87 • Number of events 1 • 12 months
|
0.00%
0/89 • 12 months
|
|
Renal and urinary disorders
Worsening renal function (serum creatinine >2.5)
|
1.1%
1/87 • Number of events 1 • 12 months
|
0.00%
0/89 • 12 months
|
|
Metabolism and nutrition disorders
Low potassium (<3.0)
|
2.3%
2/87 • Number of events 2 • 12 months
|
0.00%
0/89 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place