Trial Outcomes & Findings for CR Aim #2 - AT1 Receptor Blockade & ACE Inhibition Effect on Humoral Function (NCT NCT01678794)
NCT ID: NCT01678794
Last Updated: 2021-11-18
Results Overview
Glomerular Filtration Rate estimates how much blood passes through the glomeruli each minute. Glomeruli are the tiny filters in the kidneys that filter waste from the blood. Measured as ml/min/1.73 m2
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
baseline to 3 months
Results posted on
2021-11-18
Participant Flow
Participant milestones
| Measure |
Candesartan
Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated.
|
Placebo
Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CR Aim #2 - AT1 Receptor Blockade & ACE Inhibition Effect on Humoral Function
Baseline characteristics by cohort
| Measure |
Candesartan
n=16 Participants
Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated.
|
Placebo
n=17 Participants
Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
69.3 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 3 monthsGlomerular Filtration Rate estimates how much blood passes through the glomeruli each minute. Glomeruli are the tiny filters in the kidneys that filter waste from the blood. Measured as ml/min/1.73 m2
Outcome measures
| Measure |
Candesartan
n=16 Participants
Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated.
|
Placebo
n=17 Participants
Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated
|
|---|---|---|
|
Change in Glomerular Filtration Rate
|
-5 ml/min/1.73 m2
Interval -14.5 to 3.5
|
1.00 ml/min/1.73 m2
Interval -8.0 to 6.0
|
PRIMARY outcome
Timeframe: baseline to 3 monthsUrinary sodium excretion correlates with elevated blood pressure in subjects at low cardiovascular risk. The body continually monitors blood volume and sodium concentration. When either becomes too high, sensors in the heart, blood vessels, and kidneys detect the increases and stimulate the kidneys to increase sodium excretion, thus returning blood volume to normal. Measured as mEq/min
Outcome measures
| Measure |
Candesartan
n=16 Participants
Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated.
|
Placebo
n=17 Participants
Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated
|
|---|---|---|
|
Change in Urinary Sodium Excretion
|
-8.50 mEq/min
Interval -30.5 to 48.5
|
10.00 mEq/min
Interval -53.0 to 66.0
|
Adverse Events
Candesartan
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Candesartan
n=16 participants at risk
Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated.
|
Placebo
n=17 participants at risk
Subjects received 4 mg once a day up to 13 day. Dose was doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated
|
|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/16 • Adverse Events were collected from baseline to end of study, approximately 3 months.
|
5.9%
1/17 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Chest tightness
|
0.00%
0/16 • Adverse Events were collected from baseline to end of study, approximately 3 months.
|
5.9%
1/17 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 3 months.
|
|
Investigations
Increased plasma creatinine
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 3 months.
|
5.9%
1/17 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 3 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
18.8%
3/16 • Number of events 3 • Adverse Events were collected from baseline to end of study, approximately 3 months.
|
0.00%
0/17 • Adverse Events were collected from baseline to end of study, approximately 3 months.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/16 • Adverse Events were collected from baseline to end of study, approximately 3 months.
|
5.9%
1/17 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 3 months.
|
|
Nervous system disorders
Lightheadness
|
6.2%
1/16 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 3 months.
|
5.9%
1/17 • Number of events 1 • Adverse Events were collected from baseline to end of study, approximately 3 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place