Trial Outcomes & Findings for Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease (NCT NCT00638222)
NCT ID: NCT00638222
Last Updated: 2014-11-13
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
week 1, 8, 11, 18
Results posted on
2014-11-13
Participant Flow
Participant milestones
| Measure |
Carvedilol Then Placebo
Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
|
Placebo Then Study Drug
Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
|
All Participants
All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carvedilol and Micro T-Wave Alternans in Hypertensives With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Carvedilol Then Placebo
Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
|
Placebo Then Study Drug
Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
|
All Study Participants
n=6 Participants
All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
—
|
—
|
55 years
STANDARD_DEVIATION 15 • n=5 Participants
|
55 years
STANDARD_DEVIATION 15 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
—
|
—
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
—
|
—
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Gender
Female
|
—
|
—
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Gender
Male
|
—
|
—
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: week 1, 8, 11, 18Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 1, 8, 11, 18Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 1, 8, 11, 18Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 1, 8, 11, 18Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 1, 8, 11, 18Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 1, 8, 11, 18Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 1, 8, 11, 18Outcome measures
Outcome data not reported
Adverse Events
Carvedilol Then Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Then Study Drug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
All Study Participants
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Carvedilol Then Placebo
Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
|
Placebo Then Study Drug
Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
|
All Study Participants
n=6 participants at risk
All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
|
|---|---|---|---|
|
Cardiac disorders
Low Blood Pressure
|
—
0/0
|
—
0/0
|
16.7%
1/6 • Number of events 1
|
|
Endocrine disorders
Hypoglycemia
|
—
0/0
|
—
0/0
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
Carvedilol Then Placebo
Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
Carvedilol: Subject will receive Carvedilol over 8 weeks then receive Placebo for the 8 weeks following.
|
Placebo Then Study Drug
Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
Placebo: Subjects will receive placebo for 8 weeks then be given study drug for 8 more.
|
All Study Participants
n=6 participants at risk
All enrolled participants were randomized to receive Carvedilol or Placebo in a 2-way crossover design. Each intervention was administered over 8 weeks before switching to the alternative intervention. The study was terminated early, and data were not unblinded so participants cannot be reported separately
|
|---|---|---|---|
|
Cardiac disorders
Hypotension
|
—
0/0
|
—
0/0
|
33.3%
2/6 • Number of events 2
|
|
Cardiac disorders
Fluid Retention
|
—
0/0
|
—
0/0
|
33.3%
2/6 • Number of events 2
|
|
Cardiac disorders
Shortness of Breath
|
—
0/0
|
—
0/0
|
66.7%
4/6 • Number of events 4
|
|
General disorders
Headache
|
—
0/0
|
—
0/0
|
33.3%
2/6 • Number of events 2
|
|
Endocrine disorders
Hypoglycemia
|
—
0/0
|
—
0/0
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0
|
—
0/0
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Dry Cough
|
—
0/0
|
—
0/0
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Dry Mouth
|
—
0/0
|
—
0/0
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Pain at Dialysis Catheter Site
|
—
0/0
|
—
0/0
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Right Groin Pain
|
—
0/0
|
—
0/0
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Lower Extremity Angiogram
|
—
0/0
|
—
0/0
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Dialysis Catheter Placed
|
—
0/0
|
—
0/0
|
16.7%
1/6 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place