Trial · NCT00772941
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events - Gender. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether gender is a significant risk factor. |
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events - Age. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether age is a significant risk factor. |
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events - Chronic Obstructive Pulmonary Disease as a Complication. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether Chronic obstructive pulmonary disease as a complication is a significant risk factor. |
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Drugs. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether taking concomitant drugs is a significant risk factor. |
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events - Concomitant Therapies. | 24 weeks | Number of participants with Treatment Related Adverse Events of Varenicline to determine whether receiving concomitant therapies is a significant risk factor. |
| Primary | Risk Factors for the Frequency of Treatment Related Adverse Events - Weight at Baseline. | 24 weeks | Number of participants with Treatment Related Adverse Events to determine whether weight at baseline is a significant risk factor. |
| Primary | Risk Factors for the Proportion of Responders - Tobacco Consumption Per Day. | 24 weeks | The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants. |
| Primary | Risk Factors for the Proportion of Responders - Prolonged Administration After 12 Weeks. | 24 weeks | The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants. |
| Primary | Risk Factors for the Proportion of Responders - Antipsychotics as a Concomitant Drug. | 24 weeks | The primary analysis item was "the number of participants succeeding with continuous smoking cessation for the previous 4 weeks/the number of participants for efficacy evaluation excluding drop-out participants. |
| Primary | Number of Participants With Treatment Related Adverse Events. | 24 weeks | Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Treatment related Adverse Events were evaluated in company with the causal relationship to Varenicline. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks. |
| Primary | Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert. | 24 weeks | Adverse events mean all unfavorable events that occur in participants after administration of Varenicline, irrespective of causal relationship to Varenicline (including clinically problematic abnormal changes in laboratory test values). Numbers of Treatment Related Adverse Events were evaluated in company with the causal relationship to Varenicline. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert. The safety was evaluated on the first visit after 24 weeks; however, it was evaluated on the last visit for those who had stopped visiting before 24 weeks. |
| Secondary | Number of Participants With Continuous Abstinence Situation by 52 Weeks. | 52 weeks | Number of participants with dependence on Varenicline by 52 weeks. Varenicline-dependent Treatment Related Adverse Events are Feeling abnormal, Feeling drunk, Feeling jittery, Disturbance in attention, Dizziness, Memory impairment, Mental impairment, Psychomotor hyperactivity, Sedation, Somnolence, Confusional state, Depersonalisation, Disorientation, Dissociation, Euphoric mood, Mood variable, Mood swings, and Hallucination. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00772941/registered