Trial Outcomes & Findings for The Vascular Effects of Carvedilol Controlled Release (CR) in Abdominally Obese Hypertensive Patients (NCT NCT00459056)
NCT ID: NCT00459056
Last Updated: 2013-12-06
Results Overview
Reactive hyperemic index is a measure of endothelial function. This is measured by the ratio of post-occlusion blood volume flow versus the baseline blood volume flow. The outcome reported is the change in this ratio after the first intervention phase compared to after the second intervention phase.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
25 participants
Primary outcome timeframe
Change from three months to seven months
Results posted on
2013-12-06
Participant Flow
patients were recruited from medical clinics
Patients using anti-hypertensive medication(s) at baseline were allowed to undergo a 1-month washout prior to randomization.
Participant milestones
| Measure |
Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ
Participants were randomized to Carvedilol CR + Lisinopril for three months, then had a one month wash-out period, and then were randomized to Lisinopril + HCT for the remaining three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
|
Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril
Participants were randomized to Lisinopril + HCT for three months, then had a one month wash-out period, and then were randomized to Carvedilol CR + Lisinopril for the remaining three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, Lisinophil was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
|
|---|---|---|
|
First Intervention (First Three Months)
STARTED
|
10
|
15
|
|
First Intervention (First Three Months)
COMPLETED
|
9
|
14
|
|
First Intervention (First Three Months)
NOT COMPLETED
|
1
|
1
|
|
Washout (1 Month)
STARTED
|
9
|
14
|
|
Washout (1 Month)
COMPLETED
|
9
|
14
|
|
Washout (1 Month)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Final Three Months)
STARTED
|
9
|
14
|
|
Second Intervention (Final Three Months)
COMPLETED
|
9
|
14
|
|
Second Intervention (Final Three Months)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ
Participants were randomized to Carvedilol CR + Lisinopril for three months, then had a one month wash-out period, and then were randomized to Lisinopril + HCT for the remaining three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
|
Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril
Participants were randomized to Lisinopril + HCT for three months, then had a one month wash-out period, and then were randomized to Carvedilol CR + Lisinopril for the remaining three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, Lisinophil was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
|
|---|---|---|
|
First Intervention (First Three Months)
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
The Vascular Effects of Carvedilol Controlled Release (CR) in Abdominally Obese Hypertensive Patients
Baseline characteristics by cohort
| Measure |
Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ
n=10 Participants
Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a washout period for one month, and then were given Lisinopril + HCTZ for the final three months.
|
Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril
n=15 Participants
Participants were randomized to Lisinopril + HCTZ for the first three months, then had a washout period for one month, and then were given Carvedilol CR + Lisinopril for the final three months.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
52.7 years
STANDARD_DEVIATION 9.21 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 6.39 • n=7 Participants
|
54.0 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from three months to seven monthsPopulation: All completers were included in the analysis
Reactive hyperemic index is a measure of endothelial function. This is measured by the ratio of post-occlusion blood volume flow versus the baseline blood volume flow. The outcome reported is the change in this ratio after the first intervention phase compared to after the second intervention phase.
Outcome measures
| Measure |
Carvedilol CR + Lisinopril, Then Lisinopril +HCTZ
n=9 Participants
Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a one month washout period, then were given Lisinopril + HCTZ for the final three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
|
Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril
n=14 Participants
Participants were randomized to Lisionopril +HCTZ for the first three months, then had a one month washout period, then were given Carvedilol CR + Lisinopril for the final three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
|
|---|---|---|
|
Change in Reactive Hyperemic Index by Period (Carvedilol CR + Lisinopril vs. Lisinopril + HCTZ)
|
-0.26 Ratio
Standard Deviation 0.59
|
-0.14 Ratio
Standard Deviation 0.18
|
Adverse Events
Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place