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NCT00879177 · ClinicalTrials.gov registry record · Phase 4
Smoking Study With Behavioral Therapy for Hypertensive Patients
A Phase 4 study of Hypertension and Cigarette Smoking, sponsored by UConn Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 203
- Enrollment target
- 1
- Study location
NCT00879177: Completed Phase 4 study of Hypertension and Cigarette Smoking, sponsored by UConn Health.
NCT00879177 is a Phase 4 study of Hypertension and Cigarette Smoking that has completed, run by UConn Health. The registered enrollment target is 203 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00879177, a Phase 4 study of Hypertension and Cigarette Smoking, has completed, sponsored by UConn Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 203 participants
- Enrollment target
- 1
- Study location
Study Summary
In total, 260 patients with pre- and stage I hypertension, who are regular smokers, will be randomized to: varenicline alone or varenicline plus behavioral therapy. Patients in both conditions will receive varenicline (titrated to a maximal dose of 1.0 mg twice daily) for 12 weeks along with standard smoking cessation therapy and regular carbon monoxide (CO) and cotinine monitoring. A significantly higher proportion of behavioral therapy patients are expected to achieve and maintain long durations of abstinence than patients receiving varenicline alone. Clinic and 24-hour blood pressure (BP) and heart rate (HR) will be primary clinical outcomes. The investigators expect that BP and HR will decrease more among behavioral therapy than non-behavioral therapy patients and reductions in smoking may mediate decreases in these indices.
Conditions Studied
Interventions
- DRUG Varenicline
- BEHAVIORAL behavioral therapy
Study Locations (1)
Connecticut
- University of Connecticut Health Center - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2009-04 |
| Est. Completion | 2014-11 |
| Phase | Phase 4 |
What the finished NCT00879177 record still lists
NCT00879177 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Varenicline is the first listed.
NCT00879177 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT00879177 about?
NCT00879177 is a clinical study titled "Smoking Study With Behavioral Therapy for Hypertensive Patients". In total, 260 patients with pre- and stage I hypertension, who are regular smokers, will be randomized to: varenicline alone or varenicline plus behavioral therapy. Patients in both conditions will receive varenicline (titrated to a maximal dose of 1.0 mg twice daily) for 12 weeks along with standar...
What is the current status of trial NCT00879177?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 203 participants. The study started on 2009-04. Estimated completion is 2014-11.
What conditions does trial NCT00879177 study?
This clinical trial studies the following conditions: Hypertension, Cigarette Smoking.
What interventions are being tested in trial NCT00879177?
The interventions under investigation include: Varenicline (DRUG), behavioral therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT00879177?
This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00879177 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00879177's enrollment target sits among peer trials
203 218th of 470 higher than 253 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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