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Endothelial Function and Autonomic Regulation After Short-term Smoking Cessation: Varenicline Versus Placebo

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ClinicalTrials.gov Identifier: NCT00673595
Recruitment Status : Terminated (Difficulty with recruiting sujects and subjects complying with the protocol)
First Posted : May 7, 2008
Results First Posted : March 16, 2012
Last Update Posted : March 16, 2012
Sponsor:
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Smoking
Interventions Drug: Varenicline
Drug: Placebo
Enrollment 19
Recruitment Details Participants were recruited at the Mayo Clinic in Rochester, Minnesota from March 2007 to February 2009.
Pre-assignment Details  
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description Participants on this arm will receive varenicline tablets for 15 days. Participants on this arm will receive placebo tablets for 15 days.
Period Title: Overall Study
Started 8 11
Completed 8 11
Not Completed 0 0
Arm/Group Title Varenicline Placebo Total
Hide Arm/Group Description Participants on this arm will receive varenicline tablets for 15 days. Participants on this arm will receive placebo tablets for 15 days. Total of all reporting groups
Overall Number of Baseline Participants 8 11 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
11
 100.0%
19
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 19 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
8
 100.0%
11
 100.0%
19
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 11 participants 19 participants
8 11 19
1.Primary Outcome
Title Arterial Endothelial Function as Measured by Flow-mediated Dilation
Hide Description 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.
Time Frame 2 weeks after participants quit smoking (study visit 3, day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol; analysis was not performed.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Participants on this arm will receive varenicline tablets for 15 days.
Participants on this arm will receive placebo tablets for 15 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title 24-hour Ambulatory Blood Pressure
Hide Description Ambulatory blood pressure will be measured using the Spacelabs 90202 recorder. Systolic and diastolic blood pressure during the 24-hour period will be analyzed.
Time Frame 2 weeks after participants quit smoking (study visit 3, day 15)
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol; analysis was not performed.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
Participants on this arm will receive varenicline tablets for 15 days.
Participants on this arm will receive placebo tablets for 15 days.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Participants were followed for adverse events from randomization through 2 weeks after participants quit smoking (study visit 3, day 15).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description Participants on this arm will receive varenicline tablets for 15 days. Participants on this arm will receive placebo tablets for 15 days.
All-Cause Mortality
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/11 (0.00%) 
This study was terminated early due to difficulty with recruiting subjects and with subjects complying with the protocol.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. John H. Eisenach
Organization: Mayo Clinic
Phone: 507-266-8715
Responsible Party: John H. Eisenach, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00673595     History of Changes
Other Study ID Numbers: 06-007194
First Submitted: May 5, 2008
First Posted: May 7, 2008
Results First Submitted: February 21, 2012
Results First Posted: March 16, 2012
Last Update Posted: March 16, 2012