Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders. (CATS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01574703 |
Recruitment Status
:
Completed
First Posted
: April 10, 2012
Results First Posted
: December 29, 2016
Last Update Posted
: December 29, 2016
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label) |
Condition: |
Smoking Cessation |
Interventions: |
Drug: placebo Drug: varenicline tartrate Drug: bupropion hydrochloride Drug: Nicotine Replacement Therapy Patch |

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Of the 6293 participants who completed the parent study NCT01456936 as per protocol, a total of 4595 participants enrolled into this study NCT01574703 from 132 centers in 16 countries. |
Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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This is a non-treatment extension study of parent study NCT01456936. No study drug was provided in this extension phase. However, cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline(N=2016), bupropion(N=2006),NRT(N=2022), or placebo(N=2014) in a triple-dummy design were analyzed in this study. |
Reporting Groups
Description | |
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Varenicline | This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study. |
Bupropion | This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study. |
Nicotine Replacement Therapy (NRT) Patch | This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study. |
Placebo | This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study. |
Participant Flow: Overall Study
Varenicline | Bupropion | Nicotine Replacement Therapy (NRT) Patch | Placebo | |
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STARTED | 1192 | 1166 | 1116 | 1121 |
COMPLETED | 1067 | 1054 | 1011 | 1007 |
NOT COMPLETED | 125 | 112 | 105 | 114 |
Adverse Event | 0 | 2 | 1 | 1 |
Protocol Violation | 0 | 0 | 0 | 1 |
Unspecified Reason | 27 | 15 | 20 | 16 |
Withdrawal by Subject | 53 | 52 | 36 | 61 |
Met Withdrawal Criteria | 0 | 1 | 1 | 0 |
Lost to Follow-up | 43 | 41 | 46 | 35 |
Death | 2 | 1 | 1 | 0 |

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
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The term Baseline visit refers to the Baseline (Week 0) visit of the parent study NCT01456936. The safety population included all participants who received at least one dose of study drug in NCT01456936 parent study. The below Baseline characteristics (age, gender) are presented for all participants who entered study NCT01574703. |
Reporting Groups
Description | |
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Varenicline | This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study. |
Bupropion | This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study. |
NRT Patch | This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study. |
Placebo | This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study. |
Total | Total of all reporting groups |
Baseline Measures
Varenicline | Bupropion | NRT Patch | Placebo | Total | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Overall Participants Analyzed [Units: Participants] |
1192 | 1166 | 1116 | 1121 | 4595 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Age [Units: Years] Mean (Standard Deviation) |
48.1 (12.2) | 47.7 (12.5) | 48.3 (11.9) | 47.5 (12.2) | 47.9 (12.2) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Gender [Units: Participants] Count of Participants |
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Female | 659 55.3% | 648 55.6% | 623 55.8% | 621 55.4% | 2551 55.5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Male | 533 44.7% | 518 44.4% | 493 44.2% | 500 44.6% | 2044 44.5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||

1. Primary: | Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). ] |
2. Secondary: | Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days. ] |
3. Secondary: | Time to MACE Until the End of Study NCT01574703. [ Time Frame: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). ] |
4. Secondary: | Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). ] |
5. Secondary: | Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks). ] |
6. Secondary: | Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. ] |
7. Secondary: | Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936. [ Time Frame: Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up. ] |
8. Secondary: | Incidence of MACE Assessed Until End of Study NCT01574703. [ Time Frame: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). ] |
9. Secondary: | Incidence of MACE+ Assessed Until End of Study NCT01574703. [ Time Frame: Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703). ] |

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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No text entered. |

Certain Agreements:
Results Point of Contact:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
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Results Point of Contact:
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01574703 History of Changes |
Other Study ID Numbers: |
A3051148 2011-005513-37 ( EudraCT Number ) CATS ( Other Identifier: Alias Study Number ) |
First Submitted: | April 6, 2012 |
First Posted: | April 10, 2012 |
Results First Submitted: | July 7, 2016 |
Results First Posted: | December 29, 2016 |
Last Update Posted: | December 29, 2016 |