Trial Outcomes & Findings for Endothelial Function and Autonomic Regulation After Short-term Smoking Cessation: Varenicline Versus Placebo (NCT NCT00673595)
NCT ID: NCT00673595
Last Updated: 2012-03-16
Results Overview
Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area. This blood flow will be induced by inflation of a blood pressure cuff placed around the forearm to a pressure of at least 50 mm Hg above systolic pressure for 5 min, followed by release. The ultrasound image of the artery will be recorded continuously from 30 sec before until 2 min after cuff release.
TERMINATED
NA
19 participants
2 weeks after participants quit smoking (study visit 3, day 15)
2012-03-16
Participant Flow
Participants were recruited at the Mayo Clinic in Rochester, Minnesota from March 2007 to February 2009.
Participant milestones
| Measure |
Varenicline
Participants on this arm will receive varenicline tablets for 15 days.
|
Placebo
Participants on this arm will receive placebo tablets for 15 days.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
11
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endothelial Function and Autonomic Regulation After Short-term Smoking Cessation: Varenicline Versus Placebo
Baseline characteristics by cohort
| Measure |
Varenicline
n=8 Participants
Participants on this arm will receive varenicline tablets for 15 days.
|
Placebo
n=11 Participants
Participants on this arm will receive placebo tablets for 15 days.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=93 Participants
|
11 participants
n=4 Participants
|
19 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 weeks after participants quit smoking (study visit 3, day 15)Population: This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol; analysis was not performed.
Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area. This blood flow will be induced by inflation of a blood pressure cuff placed around the forearm to a pressure of at least 50 mm Hg above systolic pressure for 5 min, followed by release. The ultrasound image of the artery will be recorded continuously from 30 sec before until 2 min after cuff release.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeks after participants quit smoking (study visit 3, day 15)Population: This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol; analysis was not performed.
Ambulatory blood pressure will be measured using the Spacelabs 90202 recorder. Systolic and diastolic blood pressure during the 24-hour period will be analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Varenicline
Placebo
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